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21 CFR Part 806: Medical Devices; Reports of 21 CFR Part 806: Corrections and RemovalsMedical Devices; Reports of Kenneth and C. Miller Corrections Removals Lead Kenneth Compliance Officer C. Miller
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What is 21 cfr part 806?
21 CFR Part 806 is a regulation issued by the Food and Drug Administration (FDA) which requires medical device manufacturers and importers to report certain device-related actions to the FDA.
Who is required to file 21 cfr part 806?
Medical device manufacturers and importers are required to file 21 CFR Part 806.
How to fill out 21 cfr part 806?
To fill out 21 CFR Part 806, manufacturers and importers must complete the required form and submit it electronically to the FDA.
What is the purpose of 21 cfr part 806?
The purpose of 21 CFR Part 806 is to ensure timely reporting of certain device-related actions to the FDA, such as device recalls, device corrections, and removals.
What information must be reported on 21 cfr part 806?
The information that must be reported on 21 CFR Part 806 includes the device identification, reason for the action, description of the action, and contact information for the person responsible for the report.
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