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Postmarket Requirements (Devices) | FDA
- https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/postmarket-requirements-devices
- Postmarket requirements also include postmarket surveillance studies required under section 522 of the act as well as post-approval studies required at the time of approval of a premarket...
Postmarket Information - Device Surveillance and …
- https://www.fda.gov/medical-devices/human-factors-and-medical-devices/postmarket-information-device-surveillance-and-reporting-processes
- Postmarket Reporting of Adverse Events, Use Errors and Product Problems Medical Device Reporting (MDR) Applies to manufacturers, importers, and user facilities …
eCFR :: 21 CFR Part 822 -- Postmarket Surveillance
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-822
- We have the authority to order postmarket surveillance of any class II or class III medical device, including a device reviewed under the licensing provisions of section 351 of the …
Post-market surveillance of medical devices: A review
- https://pubmed.ncbi.nlm.nih.gov/35964220/
- Considering their importance in daily medical practice, the process of manufacturing, marketing and usage has to be regulated at all levels. Harmonized evidence-based …
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