The FDA published a final rule entitled Current Good Manufacturing Practice Requirements for Combination Products to provide clarification of cGMP requirements for products that are made up of a combination of devices, drugs and/or biologics. The new guideline applies to both already existing and new combination products, yet the FDA plans to issue guidance to help manufactures modify systems for products already on the market, as needed. The final rule also clarifies the cGMP requirements for “single-entity” and “co-packaged combination products.” To read an article in MassDevice, click here and to view the final rule on FDA’s website, click here.
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