Case Study: How is My Medical Device Classified?

FDA

CDRH

Center for Devices and Radiological Health

medical devices

radiation-emitting devices

device classification

product classification

Class I medical devices

Class II Medical Devices

Class III medical devices

device determination

device listing

device approval

traction device

Автор: U.S. Food and Drug Administration

Загружено: 2020-12-15

Просмотров: 7798

Описание: This CDRH Learn module provides an illustrative example of how you can determine the class of an FDA regulated medical device. Determining how a medical device is classified is instrumental in understanding and identifying the appropriate regulatory requirements for a device. To view more medical device educational resources please visit https://www.fda.gov/training-and-cont...

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Case Study: How is My Medical Device Classified?

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