FDA issues final rule on device, drug, biologic combinations

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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.

The final rule is "largely identical" to what the FDA proposed in September 2009, based off of draft guidance 1st published in 2004, which was generally met with support, according to the federal watchdog agency.

The new guidelines apply equally to existing as well as new products, despite some requests that the regulation be forward-looking only. The FDA asked makers of existing combination products to comply with the new CGMP guidelines, but promised to issue guidance to help manufacturers alter systems as need be for products already on the market.

The FDA also shielded certain manufacturers from the CGMP rules, applying the guidelines to both "specification" develops and contract manufacturers, but left out component manufacturers, even if a component will be incorporated into the final product.

Guidelines for certain combination products, such as those including parts that are separately manufactured and marketed, are straightforward, with each piece regulated under existing guidelines for its respective category.

For packages the FDA calls "single-entity and co-packaged combination products" the rules are less clear, and those combinations are the focus of the new rule.

 

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