FDA Clarifies Rules For Combination Medical Products

Law360, New York (January 18, 2013, 4:08 PM EST) -- The U.S. Food and Drug Administration issued a final rule Friday outlining which manufacturing standards applied to products featuring a blend of drugs, medical devices or biological products, after the industry asked for clear regulations on the so-called combination products.

The rule, due to be published in the Federal Register on Jan. 22, clarifies which current good manufacturing practice or quality system standard applies to different configurations of combination products, which combine types of medical product that are normally regulated by different FDA divisions.

While drugs,...
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