21 CFR 803.17
What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
21 CFR 803.17 is the regulation titled “What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?” in 21 CFR Part 803, Medical Device Reporting. Since 2021, 63 FDA warning letters have cited it.
- Letters citing it
- 63 since 2021
- Jan 1 to Oct 30, 2026
- 7 against 19 on the same dates in 2025
- Most often cited with
- 21 CFR 820.198, in 47 letters
- Closed out
- 19% of these letters have a published close-out
Letters citing it, by year issued
Most are medical device letters (62 of 63). 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 803.17 most often, as written in the letters.
- 7 lettersFailure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17
- 4 lettersFailure to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17
- 3 lettersFailure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17
The regulation
Read the text of 21 CFR 803.17 (eCFR, as of Sep 1, 2026)
If you are a user facility, importer, or manufacturer, you must develop, maintain, and implement written MDR procedures for the following:
(a) Internal systems that provide for:
(1) Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements;
(2) A standardized review process or procedure for determining when an event meets the criteria for reporting under this part; and
(3) Timely transmission of complete medical device reports to manufacturers or to us, or to both if required.
(b) Documentation and recordkeeping requirements for:
(1) Information that was evaluated to determine if an event was reportable;
(2) All medical device reports and information submitted to manufacturers and/or us;
(3) Any information that was evaluated for the purpose of preparing the submission of annual reports; and
(4) Systems that ensure access to information that facilitates timely followup and inspection by us.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 803.17.
- 21 CFR 820.198Complaint files47 letters cite both
- 21 CFR 820.30Design controls43 letters cite both
- 21 CFR 820.100Corrective and preventive action40 letters cite both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?39 letters cite both
- 21 CFR 803.3How does FDA define the terms used in this part?37 letters cite both
- 21 CFR 807.81When a premarket notification submission is required27 letters cite both
- 21 CFR 820.75Process validation21 letters cite both
- 21 CFR 820.90Nonconforming product21 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 803.17 that FDA posted most recently.
- DevicesView Chirp Innovations, LLCChirp Halo Wireless Muscle StimulatorIssuedOct 2, 2026PostedOct 27, 2026
- DevicesView Peter Schiff Enterprisescardiac electrode pads and AC cardiac fibrillatorsIssuedAug 26, 2026PostedOct 27, 2026
- DevicesView O.N. Diagnostics, LLCVirtuOst and VirtuOst VFA softwareIssuedSep 1, 2026PostedOct 6, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.