21 CFR 812.100
General responsibilities of investigators
21 CFR 812.100 is the regulation titled “General responsibilities of investigators” in 21 CFR Part 812, Investigational Device Exemptions. Since 2021, 2 FDA warning letters have cited it.
- Letters citing it
- 2 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 812.140, in 2 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
Most are biologics letters (1 of 2). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 812.100 most often, as written in the letters.
- 1 letterYou failed to ensure that the investigation was conducted in accordance with the signed agreement with the sponsor and the investigational plan. [21 CFR 812.100 and 812.110(b)]
- 1 letterYou failed to properly obtain and document legally effective informed consent in accordance with the provisions of 21 CFR Part 50.27(a) and 21 CFR 812.100
The regulation
Read the text of 21 CFR 812.100 (eCFR, as of Sep 1, 2026)
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.
[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8957, Jan. 27, 1981]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 812.100.
- 21 CFR 812.140Records2 letters cite both
- 21 CFR 50.20General requirements for informed consent1 letter cites both
- 21 CFR 50.25Elements of informed consent1 letter cites both
- 21 CFR 50.27Documentation of informed consent1 letter cites both
- 21 CFR 812.110Specific responsibilities of investigators1 letter cites both
- 21 CFR 812.150Reports1 letter cites both
- 21 CFR 812.20Application1 letter cites both
- 21 CFR 812.3Definitions1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 812.100 that FDA posted most recently.
- BiologicsView Stephen J. Fallon, Ph.D.INSTI® HIV Self-TestIssuedAug 27, 2026PostedSep 8, 2026
- DevicesView United Health Products, Inc.CelluSTAT Absorbable HemoStatIssuedMar 24, 2025PostedMay 20, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.