The US Food and Drug Administration has updated its final guidance on its Q-Submission program in line with changes negotiated in the recent medical device user fee agreement addressing issues surrounding Pre-Submissions while the agency develops a standalone draft guidance on the topic.
The most recent Medical Device User Fee Amendment (MDUFA V) included a number of new performance goals for FDA. Part of those updated performance goals includes new requirements for how FDA provides feedback through the Pre-Submission (Pre-Sub) process, which is part of the Q-Sub program.
“To address a MDUFA V commitment, the FDA intends to issue a revised draft guidance including information on when informal communication is appropriate instead of a Pre-Sub, among other updates,” said FDA. “While this new draft guidance is being developed, the FDA is making minor procedural updates and clarifications on the mechanisms that stakeholders can use to request feedback.”…
