Key Takeaway: The FDA announced a public meeting and request for comments on proposed Medical Device User Fee Amendments (MDUFA )recommendations for fiscal years 2028-2032, which would govern medical device user fees and review programs after the current authorization expires in 2027. The proposal includes new pre-submission pathways and fees, enhanced review consistency and communication measures, small business fee relief, coordinated international review pilot programs, and modernization of FDA information technology systems.
The U.S. Food and Drug Administration (FDA) has announced a public meeting and request for comments regarding proposed recommendations affecting medical device review and user fees. The release includes a draft commitments letter with recommendations on policies and procedures for the submission, review and clearance of medical devices. The recommendations are in the draft Medical Device User Fee Amendments (MDUFA) Performance Goals and Procedures and would apply for fiscal years 2028 through 2032. According to the FDA’s notice, the recommendations would govern the user fee program that supports FDA’s review of medical device submissions after the current authorization expires on September 30, 2027.
The FDA stated that the public meeting will be held on August 5, 2026, and will provide an opportunity to present views on the proposed recommendations.
Proposed changes include a new “Focused Follow-Up Pre-Submission” pathway with a 45-day response goal. The proposal would also establish a $2,000 fee for certain initial Pre-Submission requests, which would be credited toward a subsequent marketing submission fee, and would create a mechanism to request supervisory review when applicants believe they have received inconsistent FDA feedback. The recommendations also include a proposed pilot program under which the same device could be submitted simultaneously to FDA and at least two other medical device regulatory authorities for coordinated review.
The draft recommendations would continue existing review goals for many submission types, including PMAs, 510(k)s, and De Novo requests. The FDA also proposes additional efforts to improve review consistency, enhance communication in deficiency letters, and expand use of consensus standards.
The proposal also includes changes to the MDUFA fee structure. The recommendations would provide additional benefits for qualifying U.S. small businesses, including proposed registration fee waivers that would not require a showing of financial hardship.
The FDA also proposes modernization of its information technology systems, including the addition of an interactive Navigator tool to help locate public information and navigate the agency site, as well as enhancements to the Customer Collaboration Portal to better support automated submission intake, real-time verification, and two-way communications.
Those interested in the future structure of FDA’s device review programs may wish to review the draft commitment letter and fact sheet and monitor developments as the MDUFA reauthorization for 2028-2032 process moves forward.
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