Updates to the FDA’s guidance on application of user fees for combination products

The FDA just updated its guidance on Application of User Fees for Combination Products (which was last updated in 2005 and, thus, was significantly out-of-date). Questions about this subject come up from our clients, particularly those who do not have existing infrastructure to support user fees.

Helpful content in this updated guidance:

• For combination products submitted under a single application, the user fee associated with the lead type of product (drug/biologic/device) applies. This has not changed and covers the majority of cases, including all single-entity products.
• A review of waivers and reductions available under PDUFA and MDUFA are summarized.
• It is noted that, for cross-labeled combination products, when a company voluntarily submits two separate applications then both applicable fees would apply; in cases where FDA requires two separate applications (very rare),  the guidance describes which user fees would apply. The guidance goes on to describe how waivers or reductions are applied in such circumstances, particularly in the latter case (required separate applications) where some accommodations are provided.
• Points of contact are provided for the centers (CDER, CBER for PDUFA and CDRH for MDUFA) along with OCP who can be of assistance in clarifying ambiguous scenarios.

If your team needs expert guidance on compliance with the guidance update, or has questions on topics not included in the guidance / not application-related (such as annual program or site registration fees), feel free to reach out: discuss@suttonscreek.com.

AUTHOR

Jonathan Amaya-Hodges, Director, Technical Services, Suttons Creek, Inc. – 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.