All terms
5-Day Report
Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
21 CFR 803.53 requires a 5-Day Report when a manufacturer becomes aware that a reportable event necessitates remedial action to prevent unreasonable risk. Filed in addition to standard 30-day MDRs as applicable.What this means in practice
Triggers tend to be safety-relevant trends or single severe events; misreading the threshold is a common 483 finding.Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
eCFR·1FDA·2
- 1
21 CFR 803VerifiedeCFRecfr.gov
- 2
FDA MAUDE DatabaseVerifiedFDAaccessdata.fda.gov
- 3
FDA Recalls - Medical DevicesVerifiedFDAfda.gov
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