FDA Calling For More PMAs Than 510(k)s In Final Set Of Preamendment Devices
This article was originally published in The Gray Sheet
Executive Summary
“The Gray Sheet” reviewed CDRH’s proposed orders and final classification decisions on preamendment devices targeted by the 515 initiative. As of Aug. 5, FDA has proposed or finalized 14 PMAs, and proposed or finalized 10 products to be downclassified to class II with special controls.
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