Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors

Description

This guidance is intended to provide advice to sponsors, clinical investigators, and institutional review boards (IRBs) on how to determine the differences between significant risk and nonsignificant risk medical device studies.  This document supersedesSignificant Risk and Nonsignificant Risk Medical Device Studies(September 1998) Office of Health Affairs, Food and Drug Administration.  This document was revised to update the list of examples of significant and nonsignificant risk devices, to clarify the IRB’s responsibilities when making the risk determination for investigational medical devices, and to make the guidance consistent with the Agency’s good guidance practices regulations (21 CFR 10.115).

Scope & Applicability

Regulatory Context

• 21CFR812.3§ 812.3 Definitions.

  (a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended ( 21 U.S.C. 301-392 )).Read full regulation →

• 21CFR812.2§ 812.2 Applicability.

  (a) General. This part applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section.Read full regulation →

• 21CFR10.115§ 10.115 Good guidance practices.

  (a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →

• 21CFR812.20§ 812.20 Application.

  (a) Submission.Read full regulation →

• 21CFR56.108§ 56.108 IRB functions and operations.

  In order to fulfill the requirements of these regulations, each IRB shall:Read full regulation →

• 21CFR56.111§ 56.111 Criteria for IRB approval of research.

  (a) In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied:Read full regulation →

• 21CFR56.110§ 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

  (a) The Food and Drug Administration has established, and published in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The list will be amended, as appropriate, through periodic republication in the Federal Register.Read full regulation →

• Clinical Investigator

  Shirish M. Gadgeel, M.D.

  2025-09-09

• Clinical Investigator

  Mark J. Savant, M.D

  2025-07-15

• Bioresearch Monitoring Program/Institutional Review Board (IRB)

  United Health Products, Inc.

  2025-05-20

• Clinical Investigator

  Americo F. Padilla, M.D.

  2025-03-25

• Institutional Review Board (IRB)

  Armstrong County Memorial Hospital

  2024-11-05

• Clinical Investigator

  Namita A. Goyal, M.D.

  2024-10-22

• Institutional Review Board (IRB)

  Louisiana State University Health Science Center IRB

  2024-10-08

• Bioresearch Monitoring Program/IRB

  Massachusetts Institute of Technology MIT

  2024-07-16

• Clinical Investigator (Sponsor)

  Angela D. Ritter, M.D.

  2024-06-18

• Institutional Review Board (IRB)

  New York State Psychiatric Institute IRB

  2024-03-26

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