21 CFR 803.53
If I am a manufacturer, in which circumstances must I submit a 5-day report?
21 CFR 803.53 is the regulation titled “If I am a manufacturer, in which circumstances must I submit a 5-day report?” in 21 CFR Part 803, Medical Device Reporting. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 803.17, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 12021
- 02022
- 02023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 803.53 (eCFR, as of Sep 1, 2026)
You must submit a 5-day report to us with the information required by § 803.52 in accordance with the requirements of § 803.12(a) no later than 5 work days after the day that you become aware that:
(a) An MDR reportable event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. You may become aware of the need for remedial action from any information, including any trend analysis or
(b) We have made a written request for the submission of a 5-day report. If you receive such a written request from us, you must submit, without further requests, a 5-day report for all subsequent events of the same nature that involve substantially similar devices for the time period specified in the written request. We may extend the time period stated in the original written request if we determine it is in the interest of the public health.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 803.53.
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1 letter cites both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?1 letter cites both
- 21 CFR 820.100Corrective and preventive action1 letter cites both
- 21 CFR 820.160Distribution1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
- 21 CFR 820.50Purchasing controls1 letter cites both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance1 letter cites both
- 21 CFR 820.90Nonconforming product1 letter cites both
Latest letters citing it
The letter citing 21 CFR 803.53 that FDA posted most recently.
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