21 CFR 812.40
General responsibilities of sponsors
21 CFR 812.40 is the regulation titled “General responsibilities of sponsors” in 21 CFR Part 812, Investigational Device Exemptions. Since 2021, 3 FDA warning letters have cited it.
- Letters citing it
- 3 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 812.46, in 2 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are medical device letters. 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 812.40 most often, as written in the letters.
- 1 letterFailure to ensure proper monitoring and Institutional Review Board (IRB) review and approval [21 CFR 812.40]
- 1 letterFailure to ensure proper monitoring of the investigation [21 CFR 812.40]
- 1 letterFailure to ensure proper monitoring of the investigation and failure to secure clinical investigator’s compliance with investigational plans [21 CFR 812.40, 21 CFR 812.46(a)]
The regulation
Read the text of 21 CFR 812.40 (eCFR, as of Sep 1, 2026)
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.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 812.40.
- 21 CFR 812.46Monitoring investigations2 letters cite both
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 812.100General responsibilities of investigators1 letter cites both
- 21 CFR 812.140Records1 letter cites both
- 21 CFR 812.150Reports1 letter cites both
- 21 CFR 812.20Application1 letter cites both
- 21 CFR 812.3Definitions1 letter cites both
- 21 CFR 812.35Supplemental applications1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 812.40 that FDA posted most recently.
- DevicesView ExThera Medical CorporationInvestigational blood filters for clinical studiesIssuedFeb 6, 2026PostedFeb 24, 2026
- DevicesView United Health Products, Inc.CelluSTAT Absorbable HemoStatIssuedMar 24, 2025PostedMay 20, 2025
- DevicesView Nobles Medical Technology II, Inc.NobleStitch ELIssuedJan 26, 2024PostedMar 12, 2024
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Counts include every citation in a letter, as the Letters filter does. How this database is built.