Post-Market
5-Day Report
In one line
Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm.
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.
A 5-day report is also required when FDA requests one in writing. The clock starts when any employee who is a person with management or supervisory responsibilities becomes aware of the event. Remedial action can include a recall, correction or design change; if the action is not taken to prevent an unreasonable risk to public health, a 30-day report may still apply. Reports are submitted through eMDR.
Why it matters
Triggers tend to be safety-relevant trends or single severe events; misreading the threshold is a common 483 finding.
Common pitfalls
- •Misinterpreting the "unreasonable risk of substantial harm" threshold is a common compliance pitfall, leading to underreporting.
- •Failing to initiate a 5-Day Report concurrently with determining the need for remedial action can result in a late submission.
- •Assuming a 30-day MDR is always sufficient without evaluating the need for expedited reporting is a frequent mistake.
- •Inadequate documentation of the decision-making process for filing or not filing a 5-Day Report can lead to regulatory scrutiny.
- •Not clearly defining "remedial action" within internal procedures can cause confusion and reporting delays.
Sources
- 21 CFR 803 · eCFR
- FDA MAUDE Database · FDA
- FDA Recalls - Medical Devices · FDA