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Medical Device Regulatory Review Report: Guidance Regarding Information to be Included ​

Document: IMDRF/GRRP WG/N71 FINAL:2024 (Edition 2)

Official Source

https://www.imdrf.org/documents/medical-device-regulatory-review-report-guidance-regarding-information-be-included

Full Text ​

Medical Device Regulatory Review Report: Guidance Regarding Information to be Included ​

Document Number: IMDRF/GRRP WG/N71 FINAL:2024 (Edition 2)

Source: https://www.imdrf.org/documents/medical-device-regulatory-review-report-guidance-regarding-information-be-included

Final Document ​

IMDRF/GRRP WG/N71 FINAL:2024 (Edition 2)
Medical Device Regulatory Review Report: Guidance Regarding Information to be Included
Authoring Group
Good Regulatory Review Practices

Preface

© Copyright 2024 by the International Medical Device Regulators Forum.

This work is copyright. Subject to these Terms and Conditions, you may download, display, print, translate, modify and reproduce the whole or part of this work for your own personal use, for research, for educational purposes or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain all disclaimer notices as part of that reproduction. If you use any part of this work, you must include the following acknowledgement (delete inapplicable):

“[Translated or adapted] from [insert name of publication], [year of publication], International Medical Device Regulators Forum, used with the permission of the International Medical Device Regulators Forum. The International Medical Device Regulators Forum is not responsible for the content or accuracy of this [adaption/translation].”

All other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from IMDRF to do so. Requests and inquiries concerning reproduction and rights are to be sent to the IMDRF Secretariat.

Incorporation of this document, in part or in whole, into another document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the IMDRF.

Jeffrey Shuren, IMDRF Chair

Contents

Introduction 4

1. Scope 6

2. References 8

3. Definitions 9

4. Medical Device Regulatory Review Report Contents 16

Chapter 0 Regulatory Review 18

Chapter 1 Regional Administrative 19

Chapter 2 Submission Context 22

Chapter 3 Non-Clinical Evidence 23

Chapter 4 Clinical Evidence 26

Chapter 5 Labeling and Promotional Material 27

Chapter 6A Quality Management System Procedures and Chapter 6B Quality Management System Device Specific Information 29

Appendix A - Mapping of Regulatory Review Report Headings to the Essential Principles of Safety and Performance 30

Introduction ​

This is one document in a collection of documents produced by the International Medical Device Regulators Forum (IMDRF) intended to improve the efficiency and effectiveness of the regulatory review of medical devices.

IMDRF/GRRP WG/N47 (Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices) and IMDRF/GRRP WG/N52 (Principles of Labeling for Medical Devices and IVD Medical Devices) are complementary documents. These two documents are focused on the fundamental design, manufacturing, and labeling requirements for medical devices that, when met, provide assurance the device is safe and performs as intended, offers significant benefits to, among others, manufacturers, users, patients/consumers, and regulatory authorities (RAs).

IMDRF/GRRP WG/N40 (Competence, Training, and Conduct Requirements for Regulatory Reviewers), IMDRF/GRRP WG/N59 (Requirements for Medical Device Conformity Assessment Bodies for Regulatory Authority Recogn ition), and this document, IMDR/GRRP WG/N71 (Medical Device Regulatory Review Report: Guidance Regarding Information to be Included) are complementary documents. IMDRF/GRRP WG/N40 and IMDRF/GRRP WG/N59 are focused on requirements for Conformity Assessment Bodies (CABs) conducting regulatory review(s) of medical devices and in vitro diagnostic (IVD) medical devices and individuals performing regulatory reviews and other related functions under their respective medical device legislation, regulations, and procedures required in their regulatory jurisdiction. This document, IMDRF/GRRP WG/N71 expands upon section 7.5.2 of IMDRF/GRRP WG/N59 by articulating exactly the type of information a regulatory review report should include to address the requirements of section 7.7 of N59.

Specifically, IMDRF/GRRP WG/N71 provides guidance regarding creation of a medical device regulatory review report. The regulatory review report serves as a written record of the CAB’s determination of the extent of fulfillment of specified requirements. It enables the CAB to capture in a consistent manner the evidence of a manufacturer’s conformity with the criteria for the regulatory review and will facilitate the exchange of information between RAs.

Three additional documents, IMDRF/GRRP WG/N61 (Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews), IMDRF/GRRP WG/N63 (Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews), and IMDRF/GRRP WG/N66 (Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews) are complementary documents. These three documents are focused on how RAs will evaluate or “assess” a CAB’s compliance to the requirements in the IMDRF/GRRP WG/N59 and IMDRF/GRRP WG/N40 documents.

This collection of IMDRF GRRP documents will provide the fundamental building blocks by providing a common set of requirements to be utilized by the RAs for the recognition and monitoring of entities that perform regulatory reviews and other related functions. It should be noted that in some jurisdictions the recognition process is called designation, notification, registration, or accreditation.

IMDRF developed these GRRP documents to encourage and support global convergence of regulatory systems, where possible, seeking to strike a balance between the responsibilities of RAs to safeguard the health of their citizens as well as their obligations to avoid placing unnecessary burdens upon medical device CABs or the regulated industry. IMDRF RAs may add additional requirements beyond this document when their legislation requires such additions.

To prevent confusion between regulatory review activities performed by a CAB and the activities performed by medical device Regulatory Authority Assessors for CAB recognition and surveillance, in this document, the latter are designated as “assessments.”

Scope ​

The scope of this guidance document is limited to the information participating IMDRF Regulatory Authorities require in medical device regulatory review reports, the format of reports, and the information necessary for participating IMDRF RAs to effectively use the regulatory review reports in accordance with their legislation and regulations. Additional requirements for CAB certification decisions are included in IMDRF/GRRP WG/N59.

This document applies to all medical devices except IVD medical devices. This document does not apply specifically to products that do not meet the definition of a medical device in IMDRF/GRRP WG/N47 Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices. However, the contents and approach within this guidance may be relevant, as determined appropriate by the applicable RA, to documenting the evaluation of a product that is not a medical device.

This document is intended to identify the type of information a CAB would be expected to review during evaluation of a regulatory submission. This document does not apply specifically to RAs. Some RAs, however, may choose to use elements of this document in reviewing regulatory submissions themselves.

This document is intended to be used in evaluating a regulatory submission consistent with other IMDRF guidance, namely, IMDRF/RPS WG/N9. The headings in this document mirror those of IMDRF/RPS WG/N9 for consistency between information expected to be included in the regulatory submission and documentation of the CAB’s review of that submission.

IMDRF/RPS WG/N9 is primarily organized to accommodate a submission package structured with nested folders. The order of content in IMDRF/RPS WG/N9 is not intended to convey or describe the order in which content would be assembled. Similarly, the order of content in this document is not intended to convey or describe the order in which a regulatory submission would be reviewed. For example, a regulatory review report should include an evaluation of the device classification and identification information (Chapter 1.01(B)), but this evaluation requires the review of information in subsequent Chapters: Device Description (Chapter 2.04) and the Indications for Use and/or Intended Use, and Contraindications (Chapter 2.05). If the regulatory review report follows a different structure, then the report should ensure that at least the same content has been covered in the evaluation

IMDRF/RPS WG/N9 is comprehensive in scope in that it includes both common (IMDRF) and regional content. As a consequence, not all headings in IMDRF/RPS WG/N9 are applicable for all submission types and/or IMDRF jurisdictions. Similarly, not all headings of this document are relevant or reviewed to the same extent for all submission types, all device types, and/or all IMDRF jurisdictions. The relevance of each chapter and the extent of review depends on the jurisdiction(s) for which the regulatory review is being conducted.

IMDRF/RPS WG/N9 provides headings to distinguish between IMDRF and regional content. This document does not make that distinction. Instead, when developing a regulatory review report, CABs are required to review IMDRF/RPS WG/N9 and materials published by individual RAs to determine which chapters in this document are relevant based on the specific submission type, device type, and jurisdiction for which the review is being conducted. For example, Essential Principle 6.5.1 describes an essential principle of safety and performance “where a medical device incorporates, as an integral part, a substance which, if used separately may be considered to be a medicinal product/drug as defined in the relevant legislation that applies in that RA and which is liable to act upon the body with action ancillary to that of the medical device”, which may not always be applicable.

If the regulatory review report is being conducted for multiple RAs, the report should include all information relevant for all RAs for which the review is being conducted. The report should clearly indicate which elements apply to which jurisdiction.

This guidance is not intended to describe the format or contents of documentation for surveillance activities conducted by a CAB (e.g., periodic sampling). However, individual CABs may find its contents useful for such reviews if consistent with the regulatory requirements of a given jurisdiction.

This guidance does not preclude any requirements for CABs to conduct and document their own assessments. Given variability in definitions and review practices across jurisdictions, this document does not establish a regulatory pathway or describe exactly what information should be reviewed for these types of products. CABs should contact an RA if there are questions about what contents are required for a specific submission.

In addition, submissions requesting approval to conduct clinical trials are out of scope for this document; refer to each specific regulator for guidance regarding approval to conduct clinical trials.

References ​

  • IMDRF/GRRP WG/N40:2024 Competence, Training, and Conduct Requirements for Regulatory Reviewers
  • IMDRF/GRRP WG/N47:2024 Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
  • IMDRF/Standards WG/N51:2018 Optimizing Standards for Regulatory Use
  • IMDRF/GRRP WG/N52:2024 Principles of Labeling for Medical Devices and IVD Medical Devices
  • IMDRF/GRRP WG/N59:2024 Requirements for Medical Device Conformity Assessment Bodies for Regulatory Authority Recognition
  • IMDRF/GRRP WG/N61:2024 Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
  • IMDRF/GRRP WG/N63:2024 Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
  • IMDRF/GRRP WG/N66:2024 Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews
  • IMDRF/RPS WG/N9:2019 (Edition 3) Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nlVDMAToC)
  • ISO/IEC 17065:2012 Conformity assessment — Requirements for bodies certifying products, processes, and services
  • GHTF/SG1/N055:2009 Definition of the Terms Manufacturer, Authorized Representative, Distributor, and Importer

Definitions ​

Assessment : A systematic, independent, and documented process for obtaining assessment evidence and evaluating it objectively to determine the extent to which assessment criteria are fulfilled. (IMDRF/GRRP WG/N63:2024) ​

Assessor : An employee of a Regulatory Authority with the demonstrated personal attributes and competence to conduct an assessment of a Conformity Assessment Body. (IMDRF/GRRP WG/N61:2024) ​

Audit: Process for obtaining relevant information about an object of conformity assessment and evaluating it objectively to determine the extent to which specified requirements are fulfilled. (ISO 17000:2020) ​

NOTE: In this document, “audit” refers to an internally or externally activity performed by the CAB itself, and not to activities performed by non-Regulatory Authorities to determine a medical device manufacturer’s conformity with quality management system requirements or other medical device regulatory requirements. ​

Clinical Evidence : The clinical data and the clinical evaluation report pertaining to a medical device. (GHTF/SG5/N1R8:2007) ​

Conformity Assessment Body (CAB): A body other than a Regulatory Authority engaged in determining whether the relevant requirements in technical regulations or standards are fulfilled. (IMDRF/GRRP WG/N40:2024) ​

Contraindication : Labelling elements that describe situations, such as patient populations, medical reasons, or clinical conditions, in which the device should not be used because the risk of use clearly outweighs any possible benefit. (IMDRF/GRRP WG/N52:2024) ​

Effective : The ability of a medical device or IVD medical device to provide clinically significant results in a significant portion of the target population. ​

NOTE: This ability is assessed in situations where the medical device or IVD medical device is used for its intended uses and conditions of use and accompanied by adequate directions for use and warnings against unsafe use. (IMDRF/GRRP WG/N47:2024) ​

Expiry Date/Expiration Date : Upper limit of the time interval during which the safety and performance characteristics of a material stored under specified conditions can be assured. ​

NOTE 1: This also applies to medical devices whose physical, chemical or functional properties are maintained during a specified and known period, such as for capital equipment. ​

NOTE 2: Expiry dates are assigned to IVD reagents, calibrators, control materials and other components by the manufacturer, based on experimentally determined stability properties. ​

(IMDRF/GRRP WG/N52:2024) ​

Hazard : Potential source of harm. (ISO/IEC Guide 51:2014) ​

Indications for Use : A general description of the disease or condition the medical device or IVD medical device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the medical device or IVD medical device is intended. (IMDRF/GRRP WG/N52:2024) ​

Intended Use / Intended Purpose : The objective intent regarding the use of a product, process or service as reflected in the specifications, instructions and information provided by the manufacturer. ​

NOTE 1: The intended use/intended purpose are also part of promotional or sales materials or statements, although these materials lie outside the scope of this document. ​

NOTE 2: The intended use can include the indications for use. ​

(IMDRF/GRRP WG/N52:2024) ​

Instructions for Use : General and technical information provided by the manufacturer to inform the user of the medical device or IVD medical device’s intended purpose and proper use and of any contraindications, warnings, or precautions to be taken. It is provided by the manufacturer to support and assist the device users in its safe and appropriate use. (GHTF/SG1/N70:2011) ​

NOTE: Instructions for use can also be referred to as “package insert.” ​

In Vitro Diagnostic (IVD) Medical Device : ‘In Vitro Diagnostic (IVD) medical device’ means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. ​

NOTE 2: In some jurisdictions, certain IVD medical devices may be covered by other regulations. ​

(GHTF/SG1/N71:2012) ​

Label : Written, printed, or graphic information either appearing on the medical device itself, or on the packaging of each unit, or on the packaging of multiple devices. (GHTF/SG1/N70:2011) ​

NOTE: The definition above refers to the human readable label. ​

NOTE 1: Labelling can also be referred to as “information supplied by the manufacturer.” ​

NOTE 2: Labelling can be in printed or electronic format and may either physically accompany the medical device or direct the user to where the labelling information can be accessed (such as through a website), as permitted by regulatory jurisdiction. ​

Lay User : Individual who does not have formal training in a relevant field or discipline. ​

NOTE 1: Principles for lay person(s) may also apply to self-testing for an IVD medical device. ​

NOTE 2: For an IVD medical device for self-collection or self-testing, a self-collector or self-tester is considered a lay user. ​

(IMDRF/GRRP WG/N52:2024) ​

NOTE 2: The manufacturer’s responsibilities are described in other GHTF and IMDRF guidance documents. These responsibilities include meeting regulatory requirements at various points during the product lifecycle, such as adverse event reporting and notification of corrective actions. ​

NOTE 3: ‘Design and/or manufacture’, as referred to in the above definition, may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose. ​

NOTE 4: Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device. ​

NOTE 5: Any person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and who makes it available for use under his own name, should be considered the manufacturer of the modified medical device. ​

NOTE 6: An authorized representative, distributor or importer who only adds its own address and contact details to the medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer. ​

NOTE 7: To the extent that an accessory is subject to the regulatory requirements of a medical device[2], the person responsible for the design and/or manufacture of that accessory is considered to be a manufacturer. ​

Medical device: Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of: ​

diagnosis, prevention, monitoring, treatment or alleviation of disease, ​

diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury, ​

investigation, replacement, modification, or support of the anatomy, or of a physiologi­cal process, ​

supporting or sustaining life, ​

control of conception, ​

cleaning, disinfection, or sterilization of medical devices, ​

providing information by means of in vitro examination of specimens derived from the human body; ​

and does not achieve its primary intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. ​

NOTE 1: Products which may be considered to be medical devices in some jurisdictions but not in others include: ​

disinfection substances, ​

aids for persons with disabilities, ​

devices incorporating animal and/or human tissues, ​

devices for in-vitro fertilization or assisted reproduction technologies. ​

(Modified from GHTF/SG1/N71:2012) ​

NOTE 2: For clarification purposes, in certain regulatory jurisdictions, devices for cosmetic/aesthetic purposes are also considered medical devices.

NOTE 3: For clarification purposes, in certain regulatory jurisdictions, the commerce of devices incorporating human tissues is not allowed.

Model : The name and/or number used to represent one medical device, or a family of medical devices to group many variations that have shared characteristics. (IMDRF/RPS WG/N19:2016) ​

Packaging : Product to be used for the containment, protection, handling, delivery, storage, transport and presentation of goods, from raw materials to processed goods, from the producer to the user or consumer, including processor, assembler or other intermediary. (ISO 21067-1:2016) ​

Patient : An individual under the care of a healthcare provider who may benefit from the action of a medical device. A patient may also be a user of a medical device. (IMDRF/GRRP WG/N52:2024) ​

Performance : The ability of a medical device to achieve its intended purpose as stated by the manufacturer. Performance may include both clinical and technical aspects. (IMDRF/GRRP WG/N52:2024) ​

Precaution : Information regarding any special care users should exercise for the safe and effective use of the device or IVD device, or to avoid damage to the device or IVD medical device that could occur as a result of use, including misuse. (IMDRF/GRRP WG/N52:2024) ​

Quality Management System : A QMS comprises activities by which the organization identifies its objectives and determines the processes and resources required to achieve desired results. The QMS manages the interacting processes and resources required to provide value and realize results for relevant interested parties. The QMS enables top management to optimize the use of resources considering the long and short term consequences of their decision. A QMS provides the means to identify actions to address intended and unintended consequences in providing products and services. (ISO 9000:2015, Clause 2.2) ​

Regulatory Authority: A government body or other entity that exercises a legal right to control the use or sale of medical devices within its jurisdiction, and that may take enforcement action to ensure that medical products marketed within its jurisdiction comply with legal requirements. (GHTF/SG1/N78:2012) ​

Regulatory Review: A review of a medical device that is conducted to assess conformity with regional regulations or standards. ​

NOTE 1: A regulatory review is performed by Regulatory Reviewer(s), and on occasion, the Regulatory Authority and/or recognized Conformity Assessment Body may consult with Technical Expert(s) to assist in specific aspects of the regulatory review process. ​

NOTE 2: Depending on the complexity of the medical device, it may be necessary for a team of Regulatory Reviewer(s) and/or Technical Expert(s) to conduct the regulatory review to ensure all required competencies are addressed. ​

NOTE 3: A regulatory review consists of an assessment of documentation and/or evaluation/testing of physical medical devices and includes the recommendation and associated decision-making processes. The scope of the review is dependent on the Regulatory Authority’s requirements. ​

(IMDRF/GRRP WG/N40:2024) ​

Regulatory Review Report: the record developed by a CAB to document a regulatory review. ​

Regulatory Reviewer: An individual from a recognized CAB responsible for routinely performing regulatory reviews of medical devices. This may include for example, premarket reviewers, product specialists, etc. (IMDRF/GRRP WG/N66:2024) ​

Risk : Combination of the probability of occurrence of harm and the severity of that harm. (ISO/IEC Guide 51:2014) ​

Safety : Freedom from unacceptable risk. (ISO/IEC Guide 51:2014) ​

Shelf-Life : Period of time until the expiry date during which a medical device or IVD medical device in its original packaging maintains its stability under the storage conditions specified by the manufacturer. ​

(IMDRF/GRRP WG/N52:2024) ​

Single Use Device : A medical device or IVD medical device that is intended to be used on an individual patient during or for a single procedure and then disposed of. It is not intended to be reprocessed and used again. (IMDRF/GRRP WG/N52:2024) ​

Stability : Ability of a medical device and IVD medical device to maintain its safety and performance characteristics within the manufacturer’s specifications over a specified period of time. ​

NOTE 1: Stability applies to ​

Sterile and non-sterile medical devices whose physical, chemical or functional properties may be altered or compromised over a stated time interval; ​

IVD reagents, calibrators and controls, when stored, transported and used in the conditions specified by the manufacturer, ​

Reconstituted lyophilized materials, working solutions and material removed from sealed containers, when prepared, used and stored according to the manufacturer’s instructions for use, ​

Measuring instruments or measuring systems after calibration. ​

NOTE 2: Stability of an IVD reagent or measuring system is normally quantified with respect to time and specified conditions ​

In terms of the duration of a time interval over which a measured property changes by a stated amount; or ​

In terms of the change of a property under specified conditions. ​

(IMDRF/GRRP WG/N52:2024) ​

Unique Device Identifier (UDI): The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific medical device on the market. The UDI is comprised of the UDI-DI and UDI-PI. (IMDRF/UDI WG/N7: 2013) ​

NOTE: The word "Unique" does not imply serialization of individual production units. ​

User : The person, professional or lay, who uses a medical device. The patient may be that user. (GHTF/SG1/N070:2011) ​

Warning : Statement that alerts users about a situation that, if not avoided, could result in hazards or other serious adverse consequences from the use of a medical device or an IVD medical device. (Modified from ISO 18113-1:2022) ​

Medical Device Regulatory Review Report Contents ​

Guidance regarding content to include in the medical device regulatory review report are provided below. The headings mirror those of IMDRF/RPS WG/N9 for consistency between information included in the regulatory submission and documentation of the CAB’s review of that submission. The heading “Chapter 0” has been added for information not included in Chapters 1-6 of IMDRF/RPS WG/N9; that is, for information relevant to the medical device regulatory review report, but not expected to be included in the regulatory submission itself. Please note the following, which apply to all headings of the report:

  • Documenting the CAB’s Evaluation

As discussed in this document, the regulatory review report should include not only a summary of the information provided by the manufacturer regarding the topic, but also an assessment by the CAB of the acceptability of this information.

This evaluation should:

  • * Include references to the relevant (i.e., key) evidence submitted by the manufacturer that has been considered.
    • Document the CAB’s final opinion on all information provided by the manufacturer related to the given topic. That is, any information provided by the manufacturer either within the initial submission or in response to interactions with the CAB should be included in the evaluation.
    • Provide a rationale for why the totality of information provided is or is not acceptable with respect to the following questions.
      • Did the provided information demonstrate conformity with the applicable Essential Principles?
      • Were conclusions supported by the results/information presented?
      • Are all issues (e.g., questions/concerns identified during the review that required interaction/communication with the manufacturer) addressed?
      • Is there any discrepancy within the manufacturer’s conclusions?
    • Describe any nonconformities remaining at the end of review that prevent a positive recommendation from the CAB.
    • Note any follow up items that the manufacturer has committed to conduct (e.g., product stability studies).

This evaluation should not include a detailed listing and history of all interactions with the manufacturer on a specific topic. Questions sent to the manufacturer by the CAB and responses (including data and corrective action plan(s)) provided by the manufacturer to address the CAB’s concerns should be either provided as an appendix of the report or maintained as a separate resource available to support the conclusions of the regulatory review. If interactions are maintained as a separate resource, the regulatory review report should include clear reference as to where the information can be found.

  • Documenting When Topics Are Related to and Impact One Another

All of the information provided in a regulatory submission is inter-related and should be reviewed as such. Conclusions drawn when reviewing the information under one heading may impact the review and conclusions drawn when reviewing the information under other headings. For example, concerns with risk management may impact the adequacy of evidence (clinical and nonclinical) provided or the appropriateness of the proposed indications for use and labeling. The report should clearly indicate where one topic impacts another topic. The report should describe any linkage between the contents under different headings and the impact of conclusions drawn for one topic on the review of related topics. For example, the report should indicate how the evaluation of testing and labeling was informed by the extent to which testing and labeling were used as mitigations for specific risks.

  • Determining Review Expectations

Review expectations should be in line with the expectations of the jurisdiction for which the regulatory review is being conducted. Review expectations may depend on a number of factors including the following.

  • * Risk classification of device type

Example: In some cases, a CAB may review the labeling components of a higher risk device in more detail compared to the review of the labeling components of a lower risk device.

  • * Risks identified for the specific device

Example: differences in device technology may require differences in review expectations even for devices with the same indications for use.

  • * Novelty and complexity of the specific device

Example: review of novel and complex devices may include additional considerations of new features, changes to use conditions or procedures, and new technology.

  • * Conformity assessment procedure applied by the manufacturer

Example: different review expectations may be relevant based on the extent to which a manufacturer relies on conformity to standards or different types of evidence

  • * IMDRF jurisdiction for which the regulatory review is being conducted

Example: one RA may expect a review of all general quality management system procedures for high risk devices, while another may accept a specific type of certificate to indicate sufficient quality management system procedures.

Prior to developing a regulatory review report, CABs are required to review materials published by individual RAs regarding the applicable review expectations (e.g., guidance and recognized standards). CABs should contact an RA if there are questions about review expectations during the review.

  • Use of “N/A”

“N/A” should not be used in the regulatory review report without an accompanying rationale. For example, a given heading may be “N/A” based on the type of device (e.g., a device that does not include software) or based on the jurisdictions for which the review is being conducted (e.g., detailed quality management procedures may not be required for 510(k) submissions to the U.S. FDA). In these cases, “N/A” may be included for a heading, but a rationale should also be provided as to why the heading is not applicable.

  • Screening Review

Section 7.3 of IMDRF/GRRP WG/N59 indicates that a CAB performs a screening review prior to evaluating the regulatory submission. This guidance does not differentiate between a screening review and an evaluation. Instead, this guidance includes all information a regulatory authority would expect to see from a CAB after a complete assessment of the regulatory submission (including both screening and evaluation).

  • Accreditation of Testing Laboratories

In some jurisdictions, the accreditation of the testing laboratory conducting the non-clinical study impacts the review of the study methods and results. Testing laboratory accreditation should be considered as appropriate for each jurisdiction.

Chapter 0 Regulatory Review ​

Information about the Conformity Assessment Body ​

The report should include:

  • the name of the CAB
  • full address
  • contact information
  • any identification numbers relevant to the CAB performing the regulatory review
  • aspects of the CAB’s scope of recognition that are relevant to the review conducted. The report should specifically confirm the CAB’s scope of recognition at the time of the regulatory review was consistent with the scope of the review conducted.

Scope of Regulatory Review ​

The report should include a summary statement that specifically indicates the scope of regulatory review consistent with section 7.7.3(a) of IMDRF/GRRP WG/N59. At a minimum, the summary statement should include the device name, device type, manufacturer name, and jurisdictions for which the regulatory review is being conducted as well as indication of whether the regulatory submission is an initial submission or includes changes to a model of the device for which a regulatory review has already been conducted. If the regulatory submission includes many different models or configurations, the report should include a discussion as to whether the submission and its review outcome apply to some or all those included devices. For example, a clinical monitoring system might include a variety of features and configurations with differing levels of complexity and risk. The report should indicate with supporting rationale, which features and configurations are within the scope of the regulatory review.

Information relevant to this heading of the report may be found in the following chapters of IMDRF/RPS WG/N9:

  • 1.01 (“Cover Letter”)
  • 1.04 (“Application Form/Administrative Information”)
  • 1.05 (“Listing of Device(s)”)
  • 2.02 (“General Summary of Submission”)

Relevant Dates ​

The report should include the dates the regulatory submission was received by the CAB and the date the CAB completed their review.

Recommendation ​

The report should include a recommendation as to whether, based on the review of provided documentation, the device conforms or does not conform to all applicable Essential Principles and other regulatory requirements. Section 7.7.3(b) of IMDRF/GRRP WG/N59, the recommendation should include clear identification of the subject medical device and its use. If certification is recommended and to be limited to a certain period of time, the report should recommend a validity or recertification period.

Summary of Review ​

The report should include a high-level summary of the review including device name, indications for use, and highlights of the review. A detailed listing of the history of interactions with the manufacturer should not be included in the summary of review. As indicated in the introductory text of section 5 “Medical Device Regulatory Review Report Contents,” interactions between the manufacturer and the CAB should be either provided as an appendix to the report or maintained as a separate resource available to support the conclusions of the regulatory review. The report should also include, as indicated in section 7.7.3(c) of IMDRF/GRRP WG/N59, a discussion of the review criteria used to assess the regulatory submission.

Comment should be provided regarding whether the Summary and Certifications for Premarket Submissions provided by the manufacturer are accurate and acceptable based on the requirements in Chapter 2.03 of IMDRF/RPS WG/N9.

Review Team ​

The report should include a listing of the names, titles, roles, and qualifications of each individual who reviewed the file or provided signatory authority.

External Consultations ​

The report should identify any consultations obtained during regulatory review from external resources, as defined in Section 6.2 of IMDRF/GRRP WG/N59 and Section 6.2.4 of IMDRF/GRRP WG/N61. The report should clearly indicate the rationale for obtaining external consultation, the expertise of the external consultant, the information provided to and received from the external consultant, and how the external consultation impacted the overall regulatory review. For example, in the course of reviewing a product that incorporates both medical device component(s) and a medicinal/drug substance, a CAB may choose to obtain external consultation regarding the drug/medicinal substance in order to inform their review of the medical device component(s).

Chapter 1 Regional Administrative ​

Cover Letter ​

Submission Type and Number ​

The report should include relevant details from the cover letter including the type of regulatory submission submitted by the manufacturer. Refer to each specific regulator for applicable submission types.

If available, the report should also include the submission number for each identifying jurisdiction. This information may not be available at the time of the CAB review given that, in some jurisdictions, the CAB review precedes the review by the RA and, therefore, assignment of a submission number by the RA. In these cases, the identifying number, if any, assigned by the CAB itself for tracking purposes should be provided for reference.

Information relevant to this heading of the report may also be found in Chapter 1.04 (“Application Form/Administrative Information”) of IMDRF/RPS WG/N9.

Device Classification and Identification Information ​

The report should include the device classification and any associated device identifiers (e.g., unique device identifiers (UDI)) required for the applicable jurisdictions. Comment should be provided regarding the degree to which the information provided supports the proposed classification as indicated in section 7.4.2 of IMDRF/GRRP WG/N59.

Information relevant to this heading of the report may also be found in Chapter 1.04 (“Application Form/Administrative Information”) of IMDRF/RPS WG/N9.

Applicable Jurisdiction(s) ​

The report should include the jurisdiction(s) for which the review is being conducted.

Submission Table of Contents ​

The report does not need to include the Table of Contents provided in the regulatory submission.

List of Terms/Acronyms ​

The report does not need to include the list of terms/acronyms provided in the regulatory submission. However, the first time an acronym or term is used in the report, the definition should be provided.

Application Form/Administrative Information ​

The report should include the name, full address, any identification numbers, and primary contact information for the applicant, manufacturer, authorized representative, etc. as required by the jurisdictions for which the regulatory review is being conducted.

Listing of Devices ​

The report should list all devices included in the regulatory submission and subject of the review.

Quality Management System, Full Quality System or Other Regulatory Certificates ​

The report should indicate whether the applicable quality management system, full quality system, or other regulatory certificates were provided and acceptable based on the jurisdictions for which the regulatory review is being conducted.

This heading of the report should also list the name(s), location(s), and scope(s) or role(s) of each manufacturing facility and/or supplier for the medical device, using the relevant information provided in the regulatory submission (i.e., Chapter 6 of IMDRF/RPS WG/N9). The report should also include a description of any relationship between facilities when there is more than one involved in the manufacturing process. Note that a manufacturing facility includes locations with responsibility for design and/or manufacture (as indicated in GHTF/SG1/N055:2009 (“ Definition of the Terms Manufacturer, Authorized Representative, Distributor, and Importer”)).

Free Sale Certificate/Certificate of Marketing Authorization ​

The report should indicate whether and what free sale certificates/certificates of marketing authorization are available and from which regulatory jurisdiction(s).

Expedited Review Documentation ​

The report should indicate whether expedited review has been requested and/or granted by the RA and what associated supporting documentation was included.

User Fees ​

User fee documentation under this heading refers to user fees paid to the RA, not the CAB. Therefore, this review of information under this heading is conducted by the RA, not by the CAB.

Pre-Submission Correspondence and Previous Regulator Interactions ​

The report should include how previous regulator interactions informed the review of the regulatory submission. This includes both a summary of previous interactions and the impact on review considerations (e.g., if specific testing is expected for a particular jurisdiction based on feedback previously provided by that RA).

Acceptance for Review Checklist ​

The report should indicate what acceptance for review checklist information was provided in the regulatory submission, whether the information was acceptable, and how the information impacted the review conducted.

Statements/Certifications/Declarations of Conformity ​

The report should indicate what statements, certifications, declarations of conformity were provided in the regulatory submission, whether the information was acceptable, and how the information impacted the review conducted.

Letters of Reference ​

The report should include reference to any applications related to the subject regulatory submission (e.g., regional document references (e.g., Master Files) or predicate device applications). Any evaluation in the remainder of the report should clearly indicate if comments and information are provided relative to the regulatory submission or a referenced application and, if so, which referenced application. In addition, review of any referenced application is limited to the scope of the letter of reference provided by the manufacturer.

Letters of Authorization ​

The report should indicate whether the applicable letters of authorization were provided based on the jurisdictions for which the regulatory review is being conducted.

Other Regional Administrative Information ​

The report should include an evaluation of any other relevant administrative information provided in the regulatory submission.

Chapter 2 Submission Context ​

Chapter Table of Contents ​

The report does not need to include the Chapter Table of Contents provided in the regulatory submission.

General Summary of Submission ​

Information from this chapter of the regulatory submission, along with analysis of its acceptability and review conclusions, should be incorporated into the Scope and Summary of Regulatory Review in Chapter 0.

Summary and Certifications for Premarket Submissions ​

The report should indicate whether the applicable summary and certifications for premarket submissions were provided and acceptable based on the jurisdictions for which the regulatory review is being conducted.

Device Description ​

The report should include a summary description of the device, its principles of operation, packaging, history of development, and reference and comparison to similar and/or previous generations of device.

Indications for Use, Intended Use, and Contraindications ​

The report should include the indications for use, intended use, intended use environment, intended patient population, intended users, and any contraindications for use. As indicated in section 7.4.3 of IMDRF/GRRP WG/N59, the CAB should ensure that the regulatory submission supports the proposed intended use of the medical device.

Global Market History ​

The report should include the global market history of the device including where the device is currently marketed and the experience in those region(s) (e.g., any incidents and/or recalls). Distinction should be made between information provided by the manufacturer and obtained by CAB reviewer(s) during research of relevant regulator databases. Relevant regulatory databases should be consulted based on the jurisdiction for which the regulatory review is being conducted.

Comment should be provided regarding whether the global market history raises any specific concerns for the regulatory review (e.g., previous recalls may result in need to ascertain whether specific failure modes have been mitigated).

Other Submission Context Information ​

The report should include an evaluation of any other submission context information provided in the regulatory submission.

Chapter 3 Non-Clinical Evidence ​

Chapter Table of Contents ​

The report does not need to include the Chapter Table of Contents provided in the regulatory submission.

Risk Management ​

The report should include an evaluation of the acceptability of the manufacturer’s risk management approach including an evaluation of whether the risk management plan was appropriate, whether all expected risks were appropriately identified and mitigated, and whether the approach is consistent with relevant Essential Principles (see Appendix A) and regulatory requirements. As indicated in section 7.4.4 of IMDRF/GRRP WG/N59, the results of an audit conducted as part of a certification scheme should be considered when the CAB conducts its review of the regulatory submission.

Comment should be provided regarding whether the review of the risk management activities raises any specific concerns for the regulatory review (e.g., risks mitigated with non-clinical studies require evaluation of the specific methods and results of those studies).

Essential Principles (EP) Checklist ​

As indicated in section 7.7.2 of IMDRF/GRRP WG/N59, the CAB should review the regulatory submission with respect to the requirements of the relevant regulatory authority. To document this review, the report should include an evaluation of the acceptability of the manufacturer’s identification of applicable Essential Principles and regulatory requirements as well as the methods used to demonstrate conformity to each. Specific attention should be paid to any Essential Principle or regulatory requirement deemed not applicable by the manufacturer.

Comment should be provided as to whether the review of the Essential Principles and regulatory requirements raises any specific concerns for the regulatory review (e.g., methods used to demonstrate conformity for each Essential Principle may indicate need for particular review of specific evidence included in the regulatory submission).

Standards (and Guidance) ​

Standards and guidance are valuable resources in determining whether appropriate activities have been conducted and whether or not the evidence provided demonstrates conformity to the relevant Essential Principles and regulatory requirements. RAs may provide information on the standards recognized and may, themselves, publish guidance. If available, this information should be consulted and considered during review of information in the regulatory submission.

The report should indicate the standards and guidance documents used by the manufacturer to develop their regulatory submission. The report should indicate whether the standards are recognized by the RA for which the regulatory review is being conducted and should also include the CAB’s evaluation of whether all appropriate guidance documents and standards were identified and used by the manufacturer in order to address the applicable regulatory requirements.

Non-clinical Studies ​

Physical and Mechanical Characterization

The report should include an evaluation of the evidence to support physical and mechanical characterization including whether or not the information provided demonstrates conformity with the relevant Essential Principles (see Appendix A) and regulatory requirements.

Chemical/Material Characterization ​

The report should include an evaluation of the evidence to support chemical/material characterization including whether or not the information provided demonstrates conformity with the relevant Essential Principles (see Appendix A) and regulatory requirements.

Electrical Systems: Safety, Mechanical, and Environmental Protection and Electromagnetic Compatibility ​

The report should include an evaluation of the evidence to support electrical systems including whether or not the information provided demonstrates conformity with the relevant Essential Principles (see Appendix A) and regulatory requirements.

Note that review of testing to support Magnetic Resonance (MR) conditional labeling and safety during anticipated conditions of use should be included under this heading of the report. This includes evaluation of

  • Magnetically induced displacement force
  • Magnetically induced torque
  • Extent of imaging artifacts
  • Radiofrequency (RF)-induced heating or heating induced by time-varying magnetic field gradients
  • Gradient-induced vibration
  • Gradient-induced extrinsic electrical potential
  • Rectification of RF pulses from MR exams

Radiation Safety ​

The report should include an evaluation of the studies to support radiation safety including whether or not the information provided demonstrates conformity with the relevant Essential Principles (see Appendix A) and regulatory requirements.

Software/Firmware ​

The report should include an evaluation of the information provided to support the use of any software/firmware including whether or not the information demonstrates conformity with the relevant Essential Principles (see Appendix A) and regulatory requirements. Review of the software/firmware includes evaluation of the following topics. Chapter references relative to IMDRF/RPS WG/N9 are provided.

  • Software/firmware description (Chapter 3.05.05.01),
  • Hazard analysis (Chapter 3.05.05.02),
  • Software requirement specification (Chapter 3.05.05.03),
  • Architecture design chart (Chapter 3.05.05.04),
  • Software design specification (Chapter 3.05.05.05),
  • Traceability analysis (Chapter 3.05.05.06),
  • Software development environment description (Chapter 3.05.05.07),
  • Software verification and validation (Chapter 3.05.05.08),
  • Revision level history (Chapter 3.05.05.09),
  • Unresolved anomalies (bugs or defects) (Chapter 3.05.05.10),
  • Cybersecurity (Chapter 3.05.05.11), and
  • Interoperability (Chapter 3.05.05.12).

Biocompatibility and Toxicology Evaluation ​

The report should include an evaluation of the evidence to support biocompatibility and evaluate toxicology including whether or not the information provided demonstrates conformity with the relevant Essential Principles (see Appendix A) and regulatory requirements.

Non-Material-Mediated Pyrogenicity ​

The report should include an evaluation of the evidence to support pyrogenicity evaluation, such as endotoxin levels, including whether or not the information provided demonstrates conformity with the relevant Essential Principles (see Appendix A) and regulatory requirements.

Safety of Materials of Biological Origin ​

The report should include an evaluation of the evaluations performed to demonstrate the safety of materials of biological origin. This includes evaluation of whether or not the information provided demonstrates conformity with the relevant Essential Principles (see Appendix A) and regulatory requirements.

Sterilization Validation ​

The report should include an evaluation of the evidence supporting sterility of the device including whether or not the information provided demonstrates conformity with the relevant Essential Principles (see Appendix A) and regulatory requirements. The review of sterilization validation includes evaluation of the following topics. Chapter references relative to IMDRF/RPS WG/N9 are provided.

  • End-user sterilization (Chapter 3.05.09.01),
  • Manufacturer sterilization validation (Chapter 3.05.09.02),
  • Residual toxicity (Chapter 3.05.09.03),
  • Cleaning and disinfection validation (Chapter 3.05.09.04), and
  • Reprocessing of single use devices, validation data (Chapter 3.05.09.05).

Animal Testing ​

The report should include an evaluation of the animal testing including whether or not the studies demonstrate conformity with the relevant Essential Principles (see Appendix A) and regulatory requirements.

Usability/Human Factors ​

The report should include an evaluation of the studies assessing the instructions and/or device design relevant to the intended user in terms of impact of human behavior, abilities, limitations, and other characteristics on the ability of the device to perform as intended including whether or not the information provided demonstrates conformity with the relevant Essential Principles (see Appendix A) and regulatory requirements.

Non-clinical Bibliography ​

The report should include a summary of the sources included in the non-clinical bibliography. This includes an evaluation of whether or not the sources provide information that demonstrates conformity with the relevant Essential Principles (see Appendix A) and regulatory requirements.

Expiration Period and Packaging Validation ​

The report should include an evaluation of the expiration period/shelf life and packaging validation studies including whether or not the results demonstrate conformity with the relevant Essential Principles (see Appendix A) and regulatory requirements. The review of expiration period and packaging validation includes evaluation of the following topics. Chapter references relative to IMDRF/RPS WG/N9 are provided.

  • Product stability (Chapter 3.07.01), and
  • Packaging validation (Chapter 3.07.02).

Other Non-clinical Evidence ​

The report should include an evaluation of any other non-clinical evidence provided in the regulatory submission.

Chapter 4 Clinical Evidence ​

Chapter Table of Contents ​

The report does not need to include the Chapter Table of Contents provided in the regulatory submission.

Overall Clinical Evidence Summary ​

The report should include a summary and evaluation of the clinical evidence provided to demonstrate conformity with the relevant Essential Principles (see Appendix A) and regulatory requirements. This includes any clinical studies (pre- and/or post-market) conducted by the manufacturer and/or results of a literature review. In the case of a literature review, the report should include an evaluation of the relevance of the papers reviewed and the extent to which the products referenced are comparable to the device in question.

Comment should be provided on whether the clinical evidence provided is supportive of the device and indications for use subject in the regulatory submission as well as the qualifications of any persons involved in clinical evidence evaluation.

The report should indicate whether informed consent forms or any other information related to informed consent of patients was provided and acceptable based on the requirements in the jurisdiction for which the regulatory review is being conducted.

Investigators Sites and Investigational Review Board (IRB) Contact Information ​

The report should indicate whether investigator sites and IRB contact information were provided and acceptable based on the requirements in the jurisdiction for which the regulatory review is being conducted.

Other Clinical Evidence ​

The report should include an evaluation of any other clinical evidence provided in the regulatory submission.

Chapter 5 Labeling and Promotional Material ​

In addition to the regulatory requirements of a given jurisdiction, information regarding expectations for labeling may be found not only in IMDRF/GRRP WG/N47, but also the separate IMDRF/GRRP WG/N52 (Principles of Labeling for Medical Devices and IVD Medical Devices).

Specific attention should be paid to whether all product labeling (packaging, IFU, etc) is consistent with information (e.g., the methods and results from the non-clinical and clinical evidence) provided in the regulatory submission. Advertising and promotional materials may be considered elements of labeling in some jurisdictions, but, consistent with IMDRF/GRRP WG/N52, they are outside the scope of this document. Instead, the headings below align with the chapter headings within IMDRF/RPS WG/N9.

Individual jurisdictions may have their own regulations or requirements regarding other labeling elements or advertising and promotional materials. If necessary, this heading of the report can also be used to discuss any observations related to jurisdiction-specific regulations or requirements involving other labeling elements or advertising and promotional materials.

Chapter Table of Contents ​

The report does not need to include the Chapter Table of Contents provided in the regulatory submission.

Product/Package Labels ​

The report should include a description of the product/package labels materials provided by the manufacturer and an evaluation of whether they are in conformance with the relevant Essential Principles (see Appendix A) and regulatory requirements.

Package Insert/Instructions for Use ​

The report should include a description of the package insert/instructions for use provided by the manufacturer and an evaluation of whether they are in conformance with the relevant Essential Principles (see Appendix A) and regulatory requirements.

E-Labeling ​

The report should include a description of the e-labeling provided by the manufacturer and an evaluation of whether its format, availability, and change management are in conformance with regulatory requirements.

Physician Labeling ​

The report should include a description of the physician labeling provided by the manufacturer and an evaluation of whether it is in conformance with the relevant Essential Principles (see Appendix A) and regulatory requirements.

Patient Labeling ​

The report should include a description of the patient labeling provided by the manufacturer and an evaluation of whether it is in conformance with the relevant Essential Principles (see Appendix A) and regulatory requirements. Specific attention should be paid to whether the materials can be easily comprehended and correctly used by the user (see Section 3.05.11), particularly for devices intended to be used by lay users and not physicians.

Technical and/or Operators Manual ​

The report should include a description of the technical and/or operators manual provided by the manufacturer and an evaluation of whether it is in conformance with the relevant Essential Principles (see Appendix A) and regulatory requirements.

Patient File Stickers/Cards and Implant Registration Cards ​

The report should include a description of the patient file stickers/cards and implant registration cards provided by the manufacturer and an evaluation of whether they are in conformance with the relevant Essential Principles (see Appendix A) and regulatory requirements.

Product Brochures ​

The report should include a description of the product brochures provided by the manufacturer and an evaluation of whether they are in conformance with the relevant Essential Principles (see Appendix A) and regulatory requirements. Specific attention should be paid to whether the materials can be easily comprehended and correctly used by the user (see Section 3.05.11), particularly for devices intended to be used by lay users and not physicians, and as to whether the claims are consistent with the indications for use and information provided in the regulatory submission.

5.10 Other Labeling ​

The report should include an evaluation of any other labeling provided in the regulatory submission.

Chapter 6A Quality Management System Procedures and Chapter 6B Quality Management System Device Specific Information ​

The report should include a summary and evaluation of quality management system procedures and device specific information provided in the regulatory submission including whether the procedures and information conform to relevant Essential Principles (see Appendix A) and regulatory requirements. At a minimum, the report should include a summary of overall manufacturing methods as well as a listing of the addresses and contact information as well as roles of all sites where the device or its components are manufactured. The report should include an evaluation of whether the information provided is acceptable or raises any concerns regarding other aspects of the regulatory review.

As indicated in IMDRF/GRRP WG/N59:

  • Section 7.4.4: “If the CAB conducted an audit or receives the results of an audit as part of the marketing certification scheme, the CAB shall ensure that the audit results support the marketing submission.”
  • Section 7.5.1: “If the relevant Regulatory Authority requires QMS/GMP certification prior to marketing and an audit was not part of the CAB’s evaluation, the CAB shall ensure that the manufacturer holds appropriate QMS/GMP certification relevant to the medical device under review.”

Appendix A - Mapping of Regulatory Review Report Headings to the Essential Principles of Safety and Performance ​

The below table indicates which Essential Principles of Safety and Performance as established in IMDRF/GRRP WG/N47 are primarily reviewed under which headings of the regulatory review report.

This list is not all inclusive in that Essential Principles may be evaluated within more than one heading. For brevity, only the primary Essential Principles are listed. For example, a discussion of whether or not conformity has been demonstrated relative to Essential Principle 5.1.5 regarding elimination or reduction of risks related to use may be reviewed and discussed within any or all of the below headings of the regulatory review report:

  • Risk Management (Chapter 3.02)
  • Essential Principles Checklist (Chapter 3.03)
  • Standards (Chapter 3.04)
  • Animal Testing (Chapter 3.05.10)
  • Usability/Human Factors (Chapter 3.05.11)
  • Overall Clinical Evidence Summary (Chapter 4.02)
  • Labeling and Promotional Material (Chapter 5)

The table, however, only lists Essential Principle 5.1.5 as being primarily reviewed within Risk Management (Chapter 3.02). Where no primary heading could be identified for review of an Essential Principles, the Essential Principle is listed as being reviewed in all headings (i.e., by reviewing the totality of data provided by the manufacturer).

Regulatory Review Report HeadingEssential Principle
All - Totality of Review5.1.1 5.1.65.1.95.5.15.5.25.5.55.5.85.9.16.1.2 6.5.1
Chapter 0 Regulatory ReviewNone
Chapter 1 Regional AdministrativeNone
Chapter 2 Submission ContextNone
Chapter 3 Non-Clinical Evidence
3.01 Chapter Table of ContentsNone
3.02 Risk Management5.1.25.1.35.1.45.1.55.5.45.5.65.7.16.3.1
3.03 Essential Principles (EP) ChecklistAll
3.04 Standards (and Guidance)All
3.05 Non-clinical StudiesRefer to specific subheading
3.05.01 Physical and Mechanical Characterization5.3.15.3.4
3.05.02 Chemical/Material Characterization5.3.1
3.05.03 Electrical Systems: Safety, Mechanical, and Environmental Protection and Electromagnetic Compatibility5.3.15.5.35.6.15.6.25.6.35.6.45.6.55.7.25.7.35.7.45.7.55.7.65.7.7
3.05.04 Radiation Safety5.11.15.11.25.11.35.11.45.11.55.11.66.2.16.2.2
3.05.05 Software/Firmware5.8.15.8.25.8.35.8.45.8.5
3.05.06 Biocompatibility and Toxicology Evaluation5.3.15.3.25.3.36.1.16.1.3
3.05.07 Non-Material-Mediated Pyrogenicity5.3.15.3.25.3.3
3.05.08 Safety of Materials of Biological Origin5.13.15.13.25.13.3
3.05.09 Sterilization Validation5.1.75.4.15.4.25.4.35.4.45.4.55.4.6
3.05.10 Animal TestingDepends upon objectives of animal testing
3.05.11 Usability/Human Factors5.3.55.5.75.12.15.12.25.12.36.3.26.4.16.4.2
3.06 Non-clinical BibliographyDepends upon contents of sources
3.07 Expiration Period and Package Validation5.1.75.1.85.4.25.4.35.4.45.4.55.4.6
3.08 Other Non-clinical EvidenceDepends upon information provided
Chapter 4 Clinical Evidence
4.01 Chapter Table of ContentsNone
4.02 Overall Clinical Evidence5.2.15.2.2
4.03 Informed Consent Information5.2.15.2.2
4.04 Investigator Sites and IRB Contact Information5.2.15.2.2
4.05 Other Clinical EvidenceDepends upon information provided
Chapter 5 Labeling and Promotional Material
5.01 Chapter Table of ContentsNone
5.02 Product/Package Labels5.4.75.10.1
5.03 Package Insert/Instructions for Use5.1.45.4.75.10.1
5.04 E-Labeling5.1.45.4.75.10.1
5.05 Physician Labeling5.1.45.4.75.10.1
5.06 Patient Labeling5.1.45.4.75.10.1
5.07 Technical/Operator Manual5.1.45.4.75.10.1
5.08 Patient File Stickers/Cards and Implant Registration Cards5.4.75.10.1
5.09 Product Brochures5.4.75.10.1
5.10 Other LabelingDepends upon information provided
Chapter 6A Quality Management System Procedures and Chapter 6B Quality Management System Device Specific InformationAll4.0

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