Combination drug/device products as defined by FDA’s 21 CFR part 3 must comply with 21 CFR part 4 subpart A, current Good Manufacturing Practice (GMP) requirements for combination products (see January 2017 Final Guidance, Current Good Manufacturing Practice Requirements for Combination Products). Whether approved by CDRH, CDER or CBER, (generally only one approval is required based on the product’s most “significant” attribute or mode of action), device design controls (21 CFR part 820.30) must confirm there are no negative interactions between constituent parts and assure the combination product is safe and effective, performing as expected. Additionally, pharmaceutical quality must also address product design and development procedures, so it is critical that both sets of requirements are coordinated in the design and development stage. A reminder that cGMPs are minimum standards by which products shall be manufactured.
Oftentimes during development of combination products each product side understands their own regulatory requirements better than that of their combination component.”