FDA final guidance adds more details to Q-Sub program
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.
FDA published a temporary final guidance in 2023 while it worked on developing the updated final guidance, which is intended to provide clarity on topics such as informal communications. (RELATED: FDA updates Q-Sub guidance ahead of new Pre-Sub draft guidance, Regulatory Focus 6 June 2025)
“To address a MDUFA V commitment, the FDA intends to issue a revised draft guidance including information on when informal communication is appropriate instead of a Pre-Sub, among other updates,” said FDA in 2023. “While this new draft guidance is being developed, the FDA is making minor procedural updates and clarifications on the mechanisms that stakeholders can use to request feedback.”
While in both guidances, FDA notes that several mechanisms outside the Q-Submission program allow sponsors to get FDA feedback, the new guidance provides additional detail on what those tools may be. For instance, it notes that sponsors can get informal feedback through email or phone without filing a formal meeting submission on questions that can be answered based on an FDA reviewer’s experience and knowledge that doesn’t require additional background information, in-depth review, or other staff involvement. Sponsors can also get informal feedback on device-specific guidance documents, voluntary consensus standards unrelated to a specific device in development, and input from certain FDA websites.
Sponsors can also get informal feedback outside the Q-Submission program as part of the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot because it is not considered a part of the pre-submission program under MDUFA.
While the previous guidance referred sponsors to the PMA day-100 meetings guidance, the new guidance includes a section on the meetings. It notes that FDA must meet with sponsors within 100 days of a PMA application filing and a meeting request, which allows the agency to discuss the application's review status.
“A PMA Day 100 Meeting can be requested as part of the cover letter of a PMA application or by submitting a separate Q-Submission,” said FDA. “If this request is submitted as a separate Q-Submission, it should be submitted no later than 70 days after FDA receipt of a PMA that has been accepted for filing or 70 days after submission of the amendment that enables the PMA to be filed (“filing date”).”
“Whether requested as part of a cover letter for a PMA application or as a separate Q-Sub, FDA creates a PMA Day 100 Meeting Q-Submission and the applicant receives an acknowledgment letter with the Q-Submission number when the request is received,” the agency added.
More broadly, FDA notes the guidance gives sponsors an overview of the Q-submissions process, including how to get written feedback or schedule a meeting with regulators regarding premarket applications such as Investigational Device Exemption (IDE) applications, PMAs, Humanitarian Device Exemption (HDE) applications, De Novo requests, and 510(k) submissions. The agency also noted that as part of President Donald Trump’s executive order to withdraw 10 regulations, rules, or guidances for each new one published, the guidance was “deregulatory in nature.” (RELATED: Trump's 10-for-1 order puts pressure on FDA to find regulations to nix, Regulatory Focus 7 February 2025)
Final guidance
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