FDA issues final rule on device, drug, biologic combinations

January 22, 2013 by MassDevice staff

The FDA this week published a final rule governing Current Good Manufacturing Practice requirements for products that combine devices, drugs and/or biological products.

FDA logo

Federal regulators this week published a final rule governing Current Good Manufacturing Practice requirements for products made up of a combination of devices, drugs and/or biologics, categories which are usually regulated by separate FDA divisions.

The long-awaited rule is meant to provide clarification on CGMP requirements for products that include any fusion of the medical products either as packaged together or as a "single-entity" combination.

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