The United States Food and Drug Administration, a federal watchdog agency, issued a final ruling on Current Good Manufacturing Practices (CGMP) for biological products that combine drugs and/or medical devices. In the past, these products were regulated by different divisions of the FDA.
The new ruling provides clarification on previous CGMP requirements for products that combine different medical products. This final ruling is very similar to an FDA proposal in September of 2009, which was based off a draft guidance published in 2004. These earlier versions of the current ruling received positive support.
New guidelines will apply to new and existing products on the market, despite requests from some manufacturers to grandfather existing devices into its approval structure. The FDA requested that current manufacturers of combination biological products comply with the new regulations; however, the agency promised it would provide additional guidance to help manufacturers with regulatory compliance of existing devices.
Some manufacturers will be shielded from the CGMP rules. While the guidelines apply to both contract manufacturers and specification developers, component manufacturers will not be required to comply with CGMP. This loophole will apply to manufacturers even if their components are incorporated in a final version of a product.