What FDA published
On July 7, 2026, the Food and Drug Administration posted its draft commitment letter for the sixth reauthorization of the Medical Device User Fee Act, known as MDUFA VI. FDA announced the letter's availability, along with a public meeting and a formal comment period, in a Federal Register notice published July 8. Under MDUFA, device makers pay user fees to fund FDA's review program, and in exchange FDA commits to measurable review-time performance goals. The draft letter covers fiscal years 2028 through 2032 and will guide device review funding and operations through that period, pending finalization.
What changes for AI and digital health
The draft letter expands FDA's commitments around artificial intelligence and digital health oversight beyond what was agreed in the current MDUFA V cycle. It commits the agency to building internal reviewer expertise specifically in generative and agentic AI, a category of device and software submissions that did not exist in earlier reauthorizations. It also commits FDA to offering industry participation in pilots and regulatory sandboxes for AI-enabled devices, extending MDUFA V's earlier commitment to expand the agency's "digital health expertise" and align review processes with software lifecycles.
Separately, the letter converts FDA's Total Product Lifecycle Advisory Program, currently a pilot, into a permanent program, and it introduces a new "Focused Follow-Up Pre-Submission" pathway that FDA has committed to launch by December 30, 2027, with a 45-calendar-day target for written responses.
The performance goals attached to the funding
The draft sets specific review-time targets tied to the user fees industry pays. For 510(k) submissions received in fiscal year 2028, FDA's goal is an average decision time of 128 calendar days, stepping down each year to 112 calendar days for submissions received in fiscal year 2032. For premarket approval applications, including original PMAs and panel-track submissions, the goal is an average decision within 285 calendar days.
These are averages and program-level goals, not guarantees for any individual submission, and they apply to FDA's device review process generally, not specifically to AI-enabled devices.
What happens next
The comment period on the draft letter closes August 7, 2026. FDA has scheduled a public meeting on the draft for August 5, 2026, where industry, patient groups and other stakeholders can respond directly to the proposed terms. After that, FDA is required to finalize the commitment letter and submit its recommendations to Congress by January 15, 2027, ahead of the next MDUFA reauthorization cycle. Nothing in the draft letter is final. The AI and digital health commitments described above are proposals FDA has put forward for negotiation, and both the specific language and the performance goals can still change before the letter is finalized.
Sources
- Federal Register, "Medical Device User Fee Amendments; Public Meeting; Request for Comments" - https://www.federalregister.gov/documents/2026/07/08/2026-13778/medical-device-user-fee-amendments-public-meeting-request-for-comments
- FDA, "MDUFA Performance Goals and Procedures, Fiscal Years 2028-2032" - https://fda.gov/media/193465/download
- RAPS, "MDUFA VI: Draft commitment letter details enhancements, performance goals" - https://www.raps.org/resource/mdufa-vi-draft-commitment-letter-details-enhancements-performance-goals.html
- Holland & Knight, "FDA Releases Draft Commitments Letter for Medical Devices Review, Public Meeting Scheduled" - https://www.hklaw.com/en/insights/publications/2026/07/fda-releases-draft-commitments-letter-for-medical-devices-review
- Citeline Medtech Insight, "MDUFA VI Draft Commitment Letter Includes Faster Pre-Submission Lane, Expanded AI Commitments" - https://insights.citeline.com/medtech-insight/policy-and-regulation/us-fda/mdufa-vi-draft-commitment-letter-includes-faster-pre-submission-lane-expanded-ai-commitments-6TGJY2PI7NGYXE6X3KGLXEOJMY/