A sponsor shall supply all investigators participating in the investigation with copies of the investigational plan and the report of prior investigations of the device.
21 CFR Part 812 · Investigational Device Exemptions
§ 812.45 Informing investigators
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 § 812.45
Form FDA 483 observations citing this section, fiscal years 2010–2025 (Devices).
- Sponsor provide device information to investigators 4
FDA guidance that cites § 812.45
- Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Guidance for Industry 15 Dec 2025
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff 25 Jun 2010
Amendment history
Federal Register documents that created or amended this section.
- 45 FR 3751 18 Jan 1980