Corrections and Removal Reporting
The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) has developed an eSubmitter tool which enables program participants to voluntarily complete and submit medical device correction and removal information electronically as outlined by 21 CFR 806. Once packaged, the submission can be sent to CDRH through the FDA Electronic Submissions Gateway (ESG), an agency-wide entry point for all electronic submissions.
To prepare the report, open eSubmitter and click on “Create New Submission”. The New Submission Data Dialog box will appear. Scroll down to “CDRH: 806 Corrections and Removal Reporting” and highlight the line. Click next at the bottom of the dialog box, and start preparing the report.
In addition, CDRH Learn has a module on electronic submissions of Part 806 reports. Go to https://www.fda.gov/Training/CDRHLearn/default.htm and click on Postmarket Activities. In the Medical Device Recalls section look for the entry “Electronic Submission of 806 Reports of Corrections and Removals”.