About the Author
Proxima CRO Team
Taylor Lunsford, MGA
Regulatory Associate II
Taylor is fluent in Mandarin Chinese and has a strong background in medical interpreting and translating medical documents. Before joining Proxima, Taylor served in the Army as an intelligence analyst, instructor, translator and small-unit leader.

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) 

  1. Registration number, date the report is made, sequence number (001, 002, etc.), "C" for Correction or "R" for Removal. 
  1. Name, address, phone number, and contact person of the firm responsible for conducting the correction or removal. 
  1. Brand name and common name of the device and intended use. 
  1. FDA marketing status, i.e., 510(k), PMA, pre-amendment status, and device listing number. 
  1. Model/catalog number, lot/serial number 
  1. Manufacturer’s contact information (name, address, phone number, contact person) if it’s different from item #2 above. 
  1. Description of event(s) and the corrective and removal actions that have been and are expected to be taken. 
  1. 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. 
  1. The number of devices subject to Correction or Removal. 
  1. Date of manufacture or distribution; expiration date or expected life. 
  1. Name, address, and telephone number of all consignees (domestic and foreign) and the dates and number of devices distributed to each consignee. 
  1. A copy of all communications regarding the correction or removal. 
  1. 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).

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