The Food and Drug Administration has reached an agreement with the medical device industry on the next medical device user fee amendments, which would set how much the agency can raise in funding over five years in exchange for meeting certain performance goals.
The FDA shared a draft commitment letter on Wednesday that outlines a faster pre-submission process, addresses concerns with deficiency letters and repeats many of the previous agreement’s goals. The draft also calls for the Center for Devices and Radiological Health to disclose how many employees it has in each office twice per year and report how many people were hired annually, although the commitment doesn’t set out specific hiring goals.
The FDA’s device center plans to hold a public meeting on the next agreement, MDUFA VI, on Aug. 5, which outlines the FDA’s funding and goals from 2028 to 2032. The agency must provide a final commitment letter to Congress by Jan. 15 and legislation must be enacted by Sept. 30, 2027.
Scott Whitaker, CEO of industry trade group AdvaMed, said in a Wednesday statement that the agreement is “an important step toward preserving the seamless access to proven medtech patients deserve and the stability and predictability medtech innovators need to continue their critical work.”
Here are four takeaways from the draft commitment:
1. Hiring transparency, but no specific goals
After thousands of staff were cut from the FDA last year, industry and patient groups called for more transparency and hiring to ensure the agency is adequately staffed. Former CDRH leaders and people who work closely with the center told MedTech Dive earlier this year that the staff losses and attrition have left the remaining employees with large workloads and little support.
The FDA has not provided a number to MedTech Dive for how many employees the CDRH had at the end of its fiscal 2025 following a Freedom of Information Act request.
In meeting minutes leading up to the agreement, patient and industry groups raised concerns about the cuts and called for more transparency around staffing.
The draft MDUFA VI agreement does not set out specific hiring goals, unlike the previous agreement, but it does call for twice-yearly reports on the number of CDRH employees per office and annual reports on hiring. The agreement also calls for the FDA to hire and retain sufficient numbers of technical, scientific and other program experts to support device reviews, “consistent with what was agreed to under the MDUFA agreements.”
2. Similar review timeline goals
The latest draft agreement outlines similar goals for premarket submissions and 510(k) clearances as MDUFA V. The goal for original PMA and panel track supplement decisions is 285 calendar days, the same as the previous agreement. The goal for 510(k) decisions decreases from 128 days to 112 days over the five-year period from 2028 to 2032, also similar to the previous agreement.
In the first half of 2026, the average time to approval for original PMAs was about 599 days, and the average time for 510(k) clearance was about 156 days, according to a recent report by BTIG. The report found that timelines were taking longer on average in the first half of the year when compared with 2025.
3. A faster pre-submission pathway
The FDA plans to add a new, faster pathway for pre-submissions that would allow medical device developers to receive feedback ahead of a submission. The agency plans to introduce Focused Follow-Up Pre-Submissions by the end of 2027, where the FDA would provide a written response within 45 days.
4. Improvements to deficiency letters
The FDA also addressed improvements to deficiency letters, after some stakeholders complained about less detail in the letters. The FDA plans to conduct staff training on best practices for deficiency communication by September 2028 and develop a survey for recipients of deficiency letters by September 2029.
