When a Recall or Correction is Required
21 CFR Part 806 — Corrections and Removals
Under 21 CFR Part 806, manufacturers and importers must report to FDA when they initiate a correction or removal of a device to:
- Reduce a risk to health posed by the device; or
- Remedy a violation of the FD&C Act caused by the device that may present a risk to health
The terms "correction" and "removal" are defined:
- Correction — any repair, modification, adjustment, relabelling, destruction, or inspection of a device at the user's location
- Removal — any physical removal of a device from its point of use to some other location
When reporting is NOT required
Corrections and removals do not need to be reported when they are made to improve a device's performance or quality but do not reduce a risk to health or remedy an FD&C Act violation.
Also not required: routine servicing, modifications that are pre-planned as part of design, or corrections that address only cosmetic issues.
Timeframe for reporting
Reports must be submitted to FDA within 10 working days of initiating the correction or removal.