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General Controls for Medical Devices | FDA
- https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices
- General Controls are the basic provisions (authorities) of the May 28, 1976 Medical Device Amendments (hereafter referred to as the Amendments) to the Food, Drug and Cosmetic Act, that provide the FDA with the means of regulating devices to ensure their safety and effectiveness. The General Controls in … See more
Regulatory Controls | FDA - U.S. Food and Drug …
- https://www.fda.gov/medical-devices/overview-device-regulation/regulatory-controls
- General controls are regulatory requirements authorized by the FD&C Act, under sections 501, 502, 510, 516, 518, 519, and 520. General controls apply to all medical devices, …
Classify Your Medical Device | FDA
- https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
- Classify Your Medical Device | FDA Classify Your Medical Device The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different …
Medical Devices | FDA - U.S. Food and Drug Administration
- https://www.fda.gov/Medical-Devices
- Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in …
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