AdvaMed Welcomes Key Developments in MDUFA VI Process

WASHINGTON, D.C.-AdvaMed, the Medtech Association, today welcomed next steps in the Medical Device User Fee Amendments reauthorization process following clearance by the White House Office of Management and Budget of the draft MDUFA VI agreement.

FDA announced it will hold a public meeting on the draft agreement, providing an important opportunity for stakeholders to review and comment on it before it is transmitted to Congress for consideration.

"Advancing MDUFA VI 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," said Scott Whitaker, president and CEO of AdvaMed. "Patients rely on timely, expert FDA review of life-changing, life-saving medtech. 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."

The MDUFA program supports FDA's review of medtech by providing resources tied to performance goals, accountability measures, and process improvements. Each agreement is ultimately authorized by Congress via legislation.

The draft agreement, expressed as a commitment letter, is available here .

Details on FDA's Aug. 5 public meeting are available here . 

After the public meeting, FDA will send a final commitment letter to Congress by Jan. 15, 2027. Congress and the President must enact the legislation by Sept. 30, 2027.

AdvaMed looks forward to participating in FDA's public meeting and working with Congress to support the timely reauthorization of MDUFA