With Congressional Deadline Looming, FDA And Industry Schedule MDUFA Meeting

31 Jan 2022

The US regulatory agency has scheduled a 3 February meeting to continue negotiating a MDUFA deal with medtech representatives. Meanwhile, top lawmakers have set a 9 February deadline to be briefed on the matter.

A block calendar reading 3 February on wooden table with black background — • Source: Alamy

The US Food and Drug Administration and medtech industry representatives will sit down on 3 February to continue to hash out a Medical Device User Fee Amendment (MDUFA V) deal. The meeting is set for six days before a congressional deadline to brief lawmakers on the negotiations.

While the state of the MDUFA V deal is still uncertain, , the FDA is scheduled to meet with AdvaMed,...