A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both approved the application or supplemental application relating to the investigation or part of an investigation.
21 CFR Part 812 · Investigational Device Exemptions
§ 812.42 FDA and IRB approval
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What FDA inspectors cite under § 812.42
Form FDA 483 observations citing this section, fiscal years 2009–2021 (Devices).
- Sponsor began study before IRB/FDA approval 8
Warning letters citing § 812.42
3 FDA warning letters since 2017 cite this section :
- CAO Group, Inc. 15 Oct 2018
- Steiner Laboratories 21 Jun 2017
- Entellus Medical 6 Apr 2017
FDA guidance that cites § 812.42
- Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors 15 Aug 2023
- Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff 11 Jul 2019
- Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards draft 18 Dec 2017
- Infusion Pumps Total Product Life Cycle: Guidance for Industry and FDA Staff 2 Dec 2014
- FDA Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff 19 Aug 2014
- Considerations When Transferring Clinical Investigation Oversight to Another IRB: Guidance for IRBs, Clinical Investigators, and Sponsors 23 May 2014
- Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff 14 Feb 2013
- Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and FDA Staff 17 Apr 2010
- Establishment and Operation of Clinical Trial Data Monitoring Committees: Guidance for Clinical Trial Sponsors 28 Mar 2006
- Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors 1 Jan 2006
Amendment history
Federal Register documents that created or amended this section.
- 46 FR 8957 27 Jan 1981