FDA Redraws the Medical Device Review Clock: 510(k) Decision Target Proposed to Shrink to 112 Days

Whether medical devices reach the market in a timely manner often depends not only on technology and clinical evidence, but also on the review agency’s staffing, communication methods, and operating timelines. The U.S. Food and Drug Administration (FDA) held a public meeting on August 5 to discuss the sixth Medical Device User Fee Amendments (MDUFA VI); covering fiscal years 2028 through 2032, the program could reset the pace at which medical devices and diagnostic products enter the U.S. market.

The most striking figure in the draft is the shared “total time to decision” goal for 510(k) premarket notifications: an average of 128 calendar days in fiscal year 2028, declining annually thereafter to 112 days by 2032. Original premarket approval applications (PMAs) and supplements requiring expert panel review would remain at an average of 285 calendar days. These are overall timing metrics shared by the FDA and applicants, and do not mean that every application will receive a decision within the specified period.

The new program also seeks to address issues earlier. The FDA plans to launch “focused follow-up pre-submissions” by December 30, 2027, allowing companies to ask additional questions about specific issues arising from previous consultations, with a goal of providing written responses within 45 calendar days. For innovative devices that lack an existing predicate product and typically must follow the De Novo pathway, the draft adds a structured introductory meeting within 30 FDA workdays after the review begins, while maintaining the goal of reaching decisions on 90% of De Novo applications within 150 FDA workdays.

The reform is not solely focused on speed. The FDA plans to improve the completeness and consistency of requests for additional information, expand information systems and review staffing, and continue developing its capabilities in real-world evidence and digital health review. Another multinational pilot program would allow devices with the same intended use to be submitted simultaneously to the FDA and regulators in at least two other countries for coordinated review; the pilot results are scheduled to be released no later than September 30, 2030.

The draft also proposes transitioning the current Total Product Life Cycle Advisory Program (TAP) from a pilot into a permanent program and expanding it to all product areas within the FDA’s Office of Health Technology no later than October 2027. This voluntary program primarily serves products that have received Breakthrough Device designation and are planning pivotal studies. In addition to strengthening early interaction with the FDA, it can help companies communicate with the U.S. Centers for Medicare & Medicaid Services when a new reimbursement decision is needed. It reflects the reality that obtaining marketing authorization does not mean a product has cleared the barriers to clinical adoption and insurance reimbursement.

Background

MDUFA allows the FDA to collect fees from medical device companies and invest the resources in application review, personnel, and infrastructure; the current authorization expires on September 30, 2027. The FDA and industry representatives negotiated the draft from October 2025 through March 2026, while also consulting patient, consumer, medical, and academic groups. The public comment docket, FDA-2026-N-6655, is scheduled to close on August 7, 2026.

The current text remains a draft commitment, rather than review rules already in effect. The FDA must evaluate public comments, revise the proposal as needed, and then submit it to Congress; Congress must also enact legislation before the current authorization expires. Whether review times can be shortened as planned will ultimately depend on funding, staffing, application quality, and whether the FDA and applicants can resolve evidence gaps promptly during the review process.