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21 CFR Part 812 · Investigational Device Exemptions

§ 812.100 General responsibilities of investigators

Subpart E - Responsibilities of Investigators Official text on eCFR Amendment history

An investigator is responsible for ensuring that an investigation is conducted according to the signed agreement, the investigational plan and applicable FDA regulations, for protecting the rights, safety, and welfare of subjects under the investigator's care, and for the control of devices under investigation. An investigator also is responsible for ensuring that informed consent is obtained in accordance with part 50 of this chapter . Additional responsibilities of investigators are described in subpart G.

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 § 812.100

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Devices).

  • Investigator non-compliance with agreement/plan/regulations 251
  • Investigator lack of informed consent 85
  • Investigator lack of control of investigational devices 23
  • No investigator protection - subject rights, safety, welfare 15

Warning letters citing § 812.100

4 FDA warning letters since 2017 cite this section :

FDA guidance that cites § 812.100

Amendment history

Federal Register documents that created or amended this section.