Sponsors are responsible for selecting qualified investigators and providing them with the information they need to conduct the investigation properly, ensuring proper monitoring of the investigation, ensuring that IRB review and approval are obtained, submitting an IDE application to FDA, and ensuring that any reviewing IRB and FDA are promptly informed of significant new information about an investigation. Additional responsibilities of sponsors are described in subparts B and G.
21 CFR Part 812 · Investigational Device Exemptions
§ 812.40 General responsibilities of sponsors
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 812.40
Form FDA 483 observations citing this section, fiscal years 2009–2026 (Devices).
- Sponsors' general responsibilities 117
Warning letters citing § 812.40
6 FDA warning letters since 2017 cite this section :
- ExThera Medical Corporation 6 Feb 2026
- United Health Products, Inc. 24 Mar 2025
- Nobles Medical Technology II, Inc. 26 Jan 2024
- Kennedy, Philip R. 27 Feb 2020
- Steiner Laboratories 21 Jun 2017
- Entellus Medical 6 Apr 2017
FDA guidance that cites § 812.40
- Use of Data Monitoring Committees in Clinical Trials draft 13 Feb 2024
- A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers: Guidance for Industry 12 Apr 2023
- Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards, Investigators, and Sponsors draft 30 Mar 2023
- Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards draft 18 Dec 2017
- Considerations When Transferring Clinical Investigation Oversight to Another IRB: Guidance for IRBs, Clinical Investigators, and Sponsors 23 May 2014
- Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff 7 Nov 2013
- Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring: Guidance for Industry 7 Aug 2013
- Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff 14 Feb 2013
- IRB Continuing Review After Clinical Investigation Approval: Guidance for IRBs, Clinical Investigators, and Sponsors 27 Feb 2012
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff 25 Jun 2010
- Establishment and Operation of Clinical Trial Data Monitoring Committees: Guidance for Clinical Trial Sponsors 28 Mar 2006
Amendment history
Federal Register documents that created or amended this section.
- 45 FR 3751 18 Jan 1980