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# AdvaMed Seeks More Efficient Feedback Requests
- URL: https://www.fdaweb.com/advamed-seeks-more-efficient-feedback-requests/
- Published: 2024-05-20T12:00:00.000Z
- Updated: 2026-09-14T14:31:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157022

The Advanced Medical Technology Association (AdvaMed) says FDA’s new draft guidance on “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program" needs to explore ways of better promoting efficient and appropriate use of the program in response to increasing usage. The Q-Sub program includes Pre-Subs and Submission Issue Requests (SIRs) as formal means to receive feedback from the agency to help guide product development, preparation of a marketing submission, and the response to requests for additional information, AdvaMed notes in recent[ docket comments](https://downloads.regulations.gov/FDA-2018-D-1774-0057/attachment%5F1.pdf?ref=fdaweb.com).

“FDA has publicly stated that there has been a notable increase in Q-submission volumes since the inception of the Q-Sub program in MDFUA III,” AdvaMed says. “While this speaks to the value of the programs, it also underscores the importance of ensuring the programs, and FDA reviewer resources, are used effectively and efficiently. It is unclear if the increasing submission volume represents an overuse of the program and an underuse of more efficient methods of obtaining feedback, such as interactive review or emails and phone calls when the file is on hold.”

AdvaMed suggests that the guidance discuss the use of other methods of communicating, such as interactive review, to help with efficient and timely communications between industry and FDA. It further suggests that the updates to the Q-Sub guidance “should identify the circumstances in which an applicant’s question is most appropriate for informal communication instead of a Pre-Sub. We recommend the guidance include additional examples illustrating how informal communications can be used in lieu of Pre-Subs and SIRs.”

AdvaMed also is troubled by CDRH’s recommendations to use an electronic submission template for pre-submissions known as PreSTAR. “We appreciate these features are intended to promote consistency in submission format and content, however we are concerned that the PreSTAR template imposes limitations on the Pre-Submission content that are inconsistent with statute, regulation, and the least burdensome principles,” the group says. “More specifically, the PreSTAR template limits the number of topics that may be discussed in a Pre-Sub to four.”

AdvaMed further notes that there is no statutory or regulatory restriction limiting the number of topics in a Pre-Sub. “We are concerned that the use of eSTAR templates, which may eventually become the required submission format, is used inappropriately to mandate as requirements, or otherwise impose policy, based on recommendations made in guidance, without allowing for the flexibility necessary for users to provide an alternative approach,” it says. The group requests that CDRH assess the templates for all available submission types and ensure the templates do not implement recommendations in guidance as submission requirements.