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FDA to require premarket approval applications (PMA) for 43 "old" devices

This article was originally published in Clinica

Executive Summary

Premarket approval applications (PMAs) will be required for 43 Class III medical devices identified by the US FDA in the Federal Register of September 7th. The agency sets out its reasons for designating the preamendment devices (those marketed before May 28th, 1976, or substantially equivalent devices) as Class III. Requests for changes to classification had to be submitted by September 22nd.

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