FDA’s new draft guidance is providing clarity on cross-center master files

FDA recently issued a new draft guidance titled Cross-Center Master Files: Where to Submit that provides some basic information on master files across all medicinal product centers at FDA (CDER/CBER/CDRH/CVM) and was written by the Office of Combination Products (OCP).

While the guidance doesn’t go into detail about the contents of the master files, instead pointing to existing FDA websites on that topic, it does include a listing of which center should host the master file depending on the situation (i.e. which center will be leading the submission(s) referencing said master file). See a summary in Table 1 of the guidance. 

Additionally, the guidance notes that this should not impact any existing master files (i.e. firms do not need to resubmit or change anything that already exists due to this guidance).

Fundamentally, this aligns with Suttons Creek’s typical recommendations for drug/biologic-led combination products, which has been to submit a DMF to CDER/CBER containing the device information (which would typically be a Type V DMF) if there is a good technical reason (e.g. high complexity) or business reasons to utilize a master file. Further, the guidance does reemphasize that master files are not reviewed independent of applications referencing them.

AUTHOR

Jonathan Amaya-Hodges, Director of Consulting, Suttons Creek – Jonathan has over 16 years of multidisciplinary experience in regulated medical products (drugs, biologics, medical devices, and combination products) at multiple global companies. He has practical experience in Development/Engineering, Quality Assurance, and Regulatory Affairs for various types of combination products with a focus on drug delivery. Additional background includes digital health (including smart packaging/connected devices and software as a medical device, or SaMD) and in vitro diagnostics, along with clinical development (bridging) and lifecycle management for combination products. Jonathan engages with the global combination product community by speaking at conferences, lecturing in courses, serving key roles within prominent industry organizations, and interfacing with regulators on a variety of topics.