On 2 June 2023, the FDA published a new final guidance document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program with minor procedural updates and clarifications on the mechanisms that stakeholders can use to request feedback. Additionally, FDA intends to publish a revised draft of the guidance with information on when informal communication is appropriate instead of a Pre-Sub, among other updates.
Updates in the new final guidance include:
- An update to the stated typical time frame for holding a pre-sub meeting from 60-75 days to 70-75 days.
- Edits to Appendix 2 – Example Pre-Sub Questions with helpful clarifying information.
- Clarification on the expectations for the content and format of meeting minutes.
- Meeting minutes should summarize the entire meeting discussion but not be a transcript, document how substantial or complex issues were resolved, and include agreements and any action items. The minutes should only refer to the submitter and FDA generally without assigning statements to individuals and additional information or follow-up items that were not part of the discussion should not be added. Finally, FDA clarified that minutes can be submitted through the appropriate document control center either via mail or electronically.
- Clarification that an Accessory Classification Request is not a pre-sub, but that a pre-sub can be submitted prior to submitting an Accessory Classification Request.
- A new recommendation to obtain feedback on Predetermined Change Control Plans (PCCPs) prior to inclusion in a premarket submission.
- The addition of submissions associated with the Safer Technologies Program (STeP) as a type of pre-submission and requests for FDA feedback related to compliance actions, such as 483 observations, to aid in the preparation of a response as an “other use” of the Q-submission program.
- Clarification that requests for feedback on Medical Device Development Tools (MDDT) and Emergency Use Authorizations (EUAs) each have their own separate processes outside of the scope of the Q-submission program.
- Recommendations that eCopy submission packages to CDRH be submitted electronically via the CDRH Customer Collaboration Porta and that those to CBER be submitted electronically through the FDA Electronic Submission Gateway.
- New wording that enforces that submitters should not expect FDA to comment on new information provided after submitting the pre-submission package.
- A new statement regarding the length of the meeting: “If more than an hour is needed, the scope of the Q-Sub may be too large, and we recommend you consider limiting the scope of the submission to allow a more focused discussion that may yield more useful feedback.”
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