MDUFA VI Draft

MDUFA V expires in September 2027, and the FDA proposal for MDUFA VI was published in the Federal Register on July 8, 2026 (Docket No. FDA-2026-N-6655).

𝗠𝗮𝗿𝗸𝗲𝘁𝗶𝗻𝗴 𝗔𝘂𝘁𝗵𝗼𝗿𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻𝘀

The proposed MDUFA VI recommendations maintain the MDUFA V performance goals for marketing authorization submissions, including 510(k)s, PMAs, and biologics license applications.

FDA proposes to maintain a De Novo decision goal of 90 percent of De Novo requests receiving an MDUFA decision within 150 FDA days. 

MDUFA VI would introduce a structured Introduction Meeting between the FDA and the applicant within the first 30 days of review to promote early alignment and review efficiency, and it may include the issuance of a “Not Grantable” letter.

𝗣𝗿𝗲-𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻𝘀

MDUFA VI would maintain the FDA performance goal of providing written feedback on at least 90% of pre-submissions within 70 days or 5 calendar days before a scheduled pre-submission meeting. 

MDUFA VI would introduce the option of Focused Follow-Up Pre-Submissions, intended to address targeted follow-up questions related to the prior pre-submission. 

In addition, MDUFA VI would include a fee for initial pre-submissions to promote efficient use of the program. 

𝗢𝘁𝗵𝗲𝗿 𝗠𝗗𝗨𝗙𝗔 𝗩𝗜 𝗣𝗿𝗼𝗽𝗼𝘀𝗮𝗹𝘀

-Enhanced Use of Consensus Standards

-Continuation of the development of Real-World Data (RWD) and Real-World Evidence (RWE) methods.

-Continuation of building digital health expertise.

𝗧𝗵𝗲 𝗕𝗼𝘁𝘁𝗼𝗺 𝗟𝗶𝗻𝗲

MDUFA VI builds on the success of MDUFA V and introduces some positive changes to the pre-submission process.