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Home » MANUFACTURING SECTION OF PMA SHOULD HAVE VALIDATION STATS
MANUFACTURING SECTION OF PMA SHOULD HAVE VALIDATION STATS
March 4, 2004
The Center for Devices and Radiological Health (CDRH) wants premarket approval (PMA) applications to contain statistics in the manufacturing section that support the number of process validation runs done on devices to prove that the number was appropriate, according to an official from the center.