21 CFR Part 806 Medical Devices; Reports of Corrections and Removals - This part requires device manufacturers and importers to report promptly to the Food and Drug Administration (FDA) certain actions concerning device corrections and removals, and to maintain records of all corrections and removals regardless of whether such corrections and removals are required to be reported to FDA.
21 CFR Part 803 Medical Device Reporting - This part establishes requirements for medical device reporting. Under this part, device user facilities, importers, and manufacturers, must report deaths and serious injuries to which a device has or may have caused or contributed, must establish and maintain adverse event files, and must submit to FDA specified follow-up and summary reports.
21 CFR Part 808 Exemptions from Federal Preemption of State and Local Medical Device Requirements - This part prescribes procedures for the submission, review, and approval of applications for exemption from Federal preemption of State and local requirements applicable to medical devices under section 521 of the act. This part also contains special provisions governing the regulation of devices by States and localities
21 CFR Part 814 Premarket Approval of Medical Devices- This part prescribes procedures for the submission, review, and approval of applications for exemption from Federal preemption of State and local requirements applicable to medical devices.
