The US Food and Drug Administration has finalized an updated guidance on its Q-Submissions program that allows medtech companies to engage with regulators early in their product development process. The document is part of the agency’s commitment under the Medical Device User Fee Amendment (MDUFA V) to clarify when informal communications outside the program are appropriate.
On 28 May, FDA published the updated final guidance, which includes changes and consolidates past guidances. More specifically, the new guidance supersedes the 2023 final guidance regarding the Q-Submission Program and a 1998 guidance regarding premarket application (PMA) day-100 meetings…
