Devices

MDUFA Performance Goals, Procedures for 2028-2032

David McFarland

— 2 min read
Share

FDA has released the draft MDUFA Performance Goals and Procedures agreed to by CDRH and CBER under the MDUFA renewal of 2027. “Both FDA and the industry are committed to the spirit and letter of the goals described in this letter,” the document says.

The specific goals and procedures are listed under these headings: Shared Outcome Goals, Review Performance Goals FY 2028 through 2032 as Applied to MDUFA Cohorts; Infrastructure; Process Improvements; Performance Reports, and Definitions and Explanations of Terms.

The document contains a number of meaningful changes. While many review goals remain similar to MDUFA V, FDA is clearly emphasizing predictability, earlier engagement, fewer review cycles, and greater accountability for both reviewers and sponsors.

FDA and industry have agreed to a new "Focused Follow-Up Pre-Submission" program for sponsors that have already had an initial Pre-Sub meeting and need answers to limited follow-up questions. Key features include:

  • written response within 45 calendar days
  • no meeting required
  • intended to reduce unnecessary full Pre-Submissions
  • ineligible requests automatically converted into traditional Pre-Subs rather than rejected

The goal is to make sponsor-FDA interactions much faster during device development.

The MDUFA document includes stronger limits on "moving the goalposts." FDA expands commitments that:

  • deficiency letters must result from a complete review
  • all deficiencies should be identified together
  • later deficiencies generally cannot be added unless new information raises new issues
  • supervisory approval is required before adding new deficiencies

Industry has requested these protections for years because multiple rounds of new deficiencies have historically prolonged reviews.

Another program enhancement focuses on introduction meetings for every De Novo submission. Beginning 10/2027, FDA and sponsors will hold an introduction meeting during the first 30 FDA days of every De Novo review unless both parties agree it is unnecessary. The objective is early alignment before substantive review begins.

FDA and industry have also come to terms on a new informal communications pathway. FDA plans to allow companies to submit simple regulatory questions directly through the Customer Collaboration Portal rather than opening an entire Pre-Submission. Questions suitable for reviewer expertise can receive direct answers.The intention is that this could significantly reduce regulatory burden for straightforward issues.

Additionally, MDUFA VI includes greater predictability for pre-submission advice. FDA states that Pre-Submission feedback should not change unless:

  • new scientific evidence emerges
  • new safety/effectiveness concerns arise
  • standards of care change
  • management approves a change

Sponsors also gain an opportunity to request supervisory review if they believe FDA's later advice conflicts with earlier feedback. This addresses a longstanding industry complaint about inconsistent advice.

Read more