21 CFR 812.110
Specific responsibilities of investigators
21 CFR 812.110 is the regulation titled “Specific responsibilities of investigators” in 21 CFR Part 812, Investigational Device Exemptions. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 50.20, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a biologics letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 02025
- 12026
The regulation
Read the text of 21 CFR 812.110 (eCFR, as of Sep 1, 2026)
(a) Awaiting approval. An investigator may determine whether potential subjects would be interested in participating in an investigation, but shall not request the written informed consent of any subject to participate, and shall not allow any subject to participate before obtaining IRB and FDA approval.
(b) Compliance. An investigator shall conduct an investigation in accordance with the signed agreement with the sponsor, the investigational plan, this part and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA.
(c) Supervising device use. An investigator shall permit an investigational device to be used only with subjects under the investigator's supervision. An investigator shall not supply an investigational device to any person not authorized under this part to receive it.
(d) Financial disclosure. A clinical investigator shall disclose to the sponsor sufficient accurate financial information to allow the applicant to submit complete and accurate certification or disclosure statements required under part 54 of this chapter. The investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following completion of the study.
(e) Disposing of device. Upon completion or termination of a clinical investigation or the investigator's part of an investigation, or at the sponsor's request, an investigator shall return to the sponsor any remaining supply of the device or otherwise dispose of the device as the sponsor directs.
[45 FR 3751, Jan. 18, 1980, as amended at 63 FR 5253, Feb. 2, 1998]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 812.110.
- 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 812.100General responsibilities of investigators1 letter cites both
- 21 CFR 812.140Records1 letter cites both
Latest letters citing it
The letter citing 21 CFR 812.110 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.