Top 200 Prescription Drugs: Amendment to the FDCA

Better classification of medical devices according to their specific functions

Established performance standards for devices

Pre-market approval requirements

Conformance with GMP standards

Question

Amendment to the FDCA

Better classification of medical devices according to their specific functions

Established performance standards for devices

Pre-market approval requirements

Conformance with GMP standards

Nate Jandrin · Accepted Answer

Medical Device Amendment of 1976

Amendment to the FDCA Better classification of medical devices according to their specific functions Established performance standards for devices Pre-market approval requirements Conformance with GMP standards