§ 812.66 Significant risk device determinations

If an IRB determines that an investigation, presented for approval under § 812.2(b)(1)(ii) , involves a significant risk device, it shall so notify the investigator and, where appropriate, the sponsor. A sponsor may not begin the investigation except as provided in § 812.30(a) .

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What FDA inspectors cite under § 812.66

Form FDA 483 observations citing this section, fiscal years 2009–2022 (Devices).

• No IRB notification of significant risk determination 5

FDA guidance that cites § 812.66

• Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs 5 Feb 2025
• Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators 5 Feb 2025
• Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff 6 Sept 2019
• Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs 25 Sept 2017
• Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food and Drug Administration Staff draft 15 Jul 2016
• Considerations When Transferring Clinical Investigation Oversight to Another IRB: Guidance for IRBs, Clinical Investigators, and Sponsors 23 May 2014
• IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Guidance for IRBs, Clinical Investigators, and Sponsors 27 Aug 2013
• Frequently Asked Questions About Medical Devices: Guidance For IRBs, Clinical Investigators, and Sponsors 1 Jan 2006
• Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors 1 Jan 2006
• CHAPTER 48 - 7348.809 Bioresearch Monitoring

Amendment history

Federal Register documents that created or amended this section.

• 46 FR 8957 27 Jan 1981