Skip to main content

21 CFR Part 806 — Corrections & Removals

21 CFR Part 806 requires manufacturers and importers of medical devices to report to FDA certain corrections and removals of their devices. It is the primary regulation governing device recalls from the manufacturer's perspective.

Key definitions (§ 806.2)​

  • Correction — the repair, modification, adjustment, relabelling, destruction, or inspection of a device without its physical removal from its point of use
  • Removal — the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabelling, destruction, or inspection
  • Risk to health — a reasonable probability that use of or exposure to the device will cause serious adverse health consequences or death, OR that the device may cause temporary adverse health consequences or the probability of serious adverse consequences is remote

Reporting requirement (§ 806.10)​

Manufacturers and importers must submit a written report to FDA within 10 working days of initiating a correction or removal that was undertaken:

  • To reduce a risk to health posed by the device; or
  • To remedy a violation of the FD&C Act caused by the device that may present a risk to health

What the report must contain (§ 806.10(c))​

  • Device identification (name, model, lot/serial numbers, UDI)
  • Description of the event that prompted the action
  • Manufacturer's evaluation of the risk
  • Total number of devices distributed (domestic and international)
  • Distribution pattern
  • Number of devices subject to the correction/removal
  • Corrective action taken or planned
  • Any illness or injury information
  • Copy of any communication issued regarding the action

What does NOT require reporting (§ 806.1(b))​

Corrections and removals are not reportable when undertaken:

  • To improve device performance or quality and not to reduce a risk to health; or
  • To comply with the FD&C Act but where the violation does not present a risk to health

FDA's recall database​

All reported corrections and removals are tracked in FDA's Medical Device Recall Database, publicly searchable at accessdata.fda.gov.

Official resources​