Summary
SILVER SPRING, Md., Aug. 15, 2011 /PRNewswire-USNewswire/ -- The FDA today issued draft guidance to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices.
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Extract
Studies
Manufacturers submit PMA applications for high-risk (class III) medical devices. These applications undergo the most stringent type of FDA dev...
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