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Overview of Regulatory Requirements: Medical Devices
- https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript
- FDA has classified all medical devices into either Class I, II, and III. Currently, in the Code of Federal Regulations, there are about 1700 devices that have been classified by the FDA. They...
Classify Your Medical Device | FDA
- https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
- Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. …
Training and Continuing Education | FDA
- https://www.fda.gov/training-and-continuing-education
- Online courses for industry on safety and effectiveness of medical devices and exposure to radiation from medical devices. ORAU Free online courses for state, local, and tribal …
Overview of Medical Device Classification and …
- https://www.fda.gov/about-fda/cdrh-transparency/overview-medical-device-classification-and-reclassification
- Reclassification of Medical Devices Preamendments Devices A preamendments device is one that was in commercial distribution before May 28, 1976, the date the Medical …
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