Manufacturer Reporting of Corrections & Removals

Corrections and Removals – 21 CFR 806

Under 21 CFR 806, Medical Device Correction and Removals, manufacturers and importers are required to make a report to FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the act caused by the device which may present a risk to health. A report must be made even if the event was caused by user error. A report is not required if the information has already been provided to FDA under Medical Device Reporting (21 CFR 803) or Repurchase, Repairs or Replacement of Electronic Products (21 CFR 1004) or if the corrective or removal action was initiated by an FDA order under Medical Device Recall Authority (21 CFR 810).

Manufacturers and importers must keep records of those corrections and removals that are not required to be reported to FDA. However, if a report is not required under 21 CFR 806, the firm may voluntarily report under 21 CFR 7.

The definition of “risk to health” under 21 CFR 806 tracks the definitions of class I and class II recall in 21 CFR 7.3(m). Therefore, reports of corrections and removals are required for class I and class II recalls. Under 21 CFR 806, manufacturers and importers need not report events categorized as class III recalls under 21 CFR §7; only record keeping requirements would apply.

The following actions are exempt from the reporting requirements:

Actions taken by device manufacturers or importers to improve the performance or quality of a device but that do not reduce a risk to health posed by the device or remedy a violation of the act caused by the device,

  • Market withdrawals,
  • Routine servicing, and
  • Stock recoveries.

Who must report

Manufacturers and importers are required to report a correction or removal of a product if it involves a risk to health. Only the person that initiates the correction or removal is required to report.

When to report

The report must be submitted to FDA within 10 working days from the time the firm initiates the recall. If there is not a “risk to health” involved, a report to FDA is not required, but the manufacturer or importer must keep a record of the recall.

What to Report – §806.10(c)

  1. Registration number, date the report is made, sequence number (001, 002, etc.), “C” for Correction or “R” for Removal.
  2. Name, address, phone number, and contact person of the firm responsible for conducting the correction or removal.
  3. Brand name and common name of the device and intended use.
  4. FDA marketing status, i.e., 510(k), PMA, preamendment status and device listing number.
  5. Model/catalog number, lot/serial number
  6. Manufacturer’s contact information (name, address, phone number, contact person) if different from item #2 above.
  7. Description of event(s) and the corrective and removal actions that have been, and are expected to be taken.
  8. Any illness or injuries that have occurred with the use of the device. If applicable, include any Medical Device Report (MDR) numbers submitted under 21 CFR 803.
  9. The number of devices subject to the Correction or Removal.
  10. Date of manufacture or distribution; expiration date or expected life.
  11. Name, address, and telephone number of all consignees (domestic and foreign) and the dates and number of devices distributed to each consignee.
  12. A copy of all communications regarding the correction or removal.
  13. A statement as to why any required information is not available and a date when it will be submitted.

Where to report

Reports should be made to the FDA District Office in which the reporting facility is geographically located. Importers should contact the FDA District Office that covers their main port of entry.

Amendments

If, after submitting a report, a manufacturer or importer determines that the same correction or removal should be extended to additional lots or batches of the same device, the manufacturer or importer must amend the original report by submitting an amendment within 10-working days of initiating the extension of the correction or removal [21 CFR 806.10(d)]. The amendment should cite the original report number assigned, all of the information required by 21 CFR 806.10(c)(2), and any information required by 21 CFR 806.10(c)(3) through (c)(12) that is different from the information submitted in the original report. The manufacturer or importer must also state what required information is not readily available and a date for when it will be submitted.

Recordkeeping Requirements

The device manufacturer or importer who initiates a correction or removal of a device that is not required to be reported to FDA must maintain records of the correction or removal. Records must contain the following information:

  1. The brand name, common or usual name, classification, name and product code, if known, and the intended use of the device.
  2. The model, catalog, or code number of the device and the manufacturing lot or serial number of the device or other identification number.
  3. A description of the event(s) giving rise to the information reported and the corrective or removal action that has been, and is expected to be taken.
  4. Justification for not reporting the correction or removal action to FDA, which shall contain conclusions and any follow-ups, and be reviewed and evaluated by a designated person.
  5. A copy of all communications regarding the correction or removal.
  6. The manufacturer or importer must retain all records for a period of two years beyond the expected life of the device, even if the manufacturer or importer has ceased to manufacture or import the device. Records required to be maintained must be transferred to the new manufacturer or importer of the device and maintained for the required period of time.