Reports must be submitted to FDA within 10 working days from the time the firm initiates the correction or removal.
What to Report - §806.10(c)
- Registration number, date the report is made, sequence number (001, 002, etc.), "C" for Correction or "R" for Removal.
- Name, address, phone number, and contact person of the firm responsible for conducting the correction or removal.
- Brand name and common name of the device and intended use.
- FDA marketing status, i.e., 510(k), PMA, pre-amendment status, and device listing number.
- Model/catalog number, lot/serial number
- Manufacturer’s contact information (name, address, phone number, contact person) if it’s different from item #2 above.
- Description of event(s) and the corrective and removal actions that have been and are expected to be taken.
- 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.
- The number of devices subject to Correction or Removal.
- Date of manufacture or distribution; expiration date or expected life.
- Name, address, and telephone number of all consignees (domestic and foreign) and the dates and number of devices distributed to each consignee.
- A copy of all communications regarding the correction or removal.
- A statement as to why any required information is not available and a date when it will be submitted.
There are two ways to report corrections and removals. The FDA Electronic Submission Software (eSubmitter) or e-mail. It’s encouraged that you use eSubmitter, once a report is created, the report is sent to CDRH through the FDA Electronic Submission Gateway.
If you choose to report via email, you must e-mail it to your FDA's Office of Regulatory Affairs (ORA) Division Recall Coordinator (DRC).