On January 23, 2015, FDA issued its long-awaited guidance document on current good manufacturing practice (cGMP) requirements for combination products. The guidance, entitled Current Good Manufacturing Practice Requirements for Combination Products, comes two years after FDA’s January 22, 2013 final rule established specific combination product cGMP regulations (codified in 21 CFR Part 4).
The guidance provides an overview of FDA’s 2013 final rule and the role of the different agency components with respect to cGMP for combination products. The guidance also offers specific advice on applying certain cGMP requirements for drugs, devices, biological products, and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) to combination products. Perhaps most noteworthy in the guidance is FDA’s advice on cGMP compliance for specific types of combination products—namely, prefilled syringes, drug-coated mesh, and drug-eluting stents. This specific guidance includes hypothetical scenarios for the various product types, primarily focusing on how to streamline cGMP for those products.
Although FDA regulations permit comments to a draft guidance to be submitted at any time, the agency is requesting that interested parties submit comments on the draft guidance within 60 days of publication in the Federal Register, meaning comments will likely need to be submitted by late March 2015. We will continue to monitor future developments in this area, as FDA is likely to rely on this guidance as a tool for inspections and enforcement moving forward. The draft guidance can be found at the following link.