A faster pre-submission track, earlier communication for de novo applicants and an “international harmonization” pilot program are among proposed improvements and changes featured in the FDA’s latest draft Medical Device User Fee Amendments (MDUFA) agreement.
The agency recently released a draft commitment letter, detailing its proposed agreement with the medtech industry for MDUFA reauthorization.
If passed by Congress and signed into law, it would be the sixth version of the Medical Device User Fee and Modernization Act of 2002. AdvaMed “welcomed” next steps in the reauthorization process following yesterday’s draft MDUFA VI agreement.
Every five years, regulators and industry representatives negotiate updates to the program, which collects fees from applicants to fund FDA review.
In the recent 36-page MDUFA VI commitment letter, the FDA introduced a new, faster-turnaround pre-submission track called Focused Follow-Up Pre-Submissions. The new submission type is intended to address targeted follow-up questions related to a prior pre-submission with a written response from the agency within 45 calendar days of receipt.
The FDA plans to roll out the focused follow-up program by December 30, 2027, if the legislation passes. The existing pre-submission program will continue under the proposed agreement.
MDUFA VI also introduces a new structured introduction meeting between the FDA and de novo applicants within the first 30 FDA days of review for submissions received on or after October 1, 2027.
With the meeting, the FDA intends to “facilitate an accurate and complete understanding of the de novo request, promote review efficiency and predictability, and resolve deficiencies that can be addressed without needing to place the submission on hold,” the letter said.
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The drafted agreement features an “international harmonization” pilot program “in which the same device with the same intended use could be submitted simultaneously to the FDA and at least two other medical device regulatory authorities to support collaboration with participating regulators on a coordinated premarket review.”
Reliance on outside agencies will be limited to an “abridged approach,” the letter said, stating that the FDA may consider and leverage elements of outside assessments but retains full authority to make the final decision for authorization.
FDA said the pilot is intended to promote reliance on scientific assessments by “trusted regulatory authorities with whom confidentiality commitments exist, consistent with applicable U.S. statutory and regulatory requirements.”
The FDA also set goals to speed up the time from 510(k) submission to decision while maintaining standards for safety and effectiveness over the course of MDUFA VI’s five-year span.
For 510(k) submissions received in fiscal year 2028, the agreement sets the goal of an average time to decision within 128 calendar days. Each year, the agency plans to reduce that time, concluding with a decision goal of 112 calendar days for submissions received in fiscal year 2032.
MDUFA VI builds on MDUFA V’s commitment to expand the agency’s “digital health expertise” and “align review processes with software lifecycles in digital health products.”
In the draft, the agency proposed an expansion of technical expertise to “address rapidly evolving digital health technologies” and engage with “stakeholders through formal and informal mechanisms to explore regulatory approaches to emerging digital health technologies.”
The drafted agreement also proposes the Total Product Life Cycle Advisory Program (TAP) pilot transition into a full program covering all product areas. In the new agreement, the TAP program will feature more engagement between the FDA and the Centers for Medicare and Medicaid Services for technologies with potential new coverage determinations.
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The FDA also said it will “recruit, hire, and retain sufficient technical and scientific staff and will leverage contractual support” to support the review process. The agency will apply user fee revenue to increase review capacity by hiring device submission reviewers and contractual support, the letter said.
FDA scheduled an in-person and virtual public meeting for August 5 to discuss the proposed recommendations for MDUFA reauthorization. After the meeting, the FDA will present a final commitment letter to Congress by January 15, 2027. Congress and the President have until September 30, 2027, to pass the new legislation before the current legislation, MDUFA V, expires.
“Patients rely on timely, expert FDA review of life-changing, life-saving medtech,” AdvaMed President and CEO Scot Whitaker said in a news release. “This agreement helps provide FDA with the resources needed to support that mission, while giving medtech companies confidence to continue developing remarkable technologies for FDA review.”
