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# Don’t Impose 30-Day SIR Deadline: AdvaMed
- URL: https://www.fdaweb.com/dont-impose-30-day-sir-deadline-advamed/
- Published: 2018-08-07T12:00:00.000Z
- Updated: 2026-09-15T00:24:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142050

AdvaMed says that a provision in an FDA Q-Submission Program draft guidance extending from 21 to 70 days the agency’s feedback timeline for submission issue requests (SIRs) received after the 30-day deadline after a marketing submission hold “risks counterproductive results.” In its comment [letter](https://www.regulations.gov/document?D=FDA-2018-D-1774-0008&ref=fdaweb.com), AdvaMed says that while it shares the agency’s interest in reducing time to decision, a 30-day SIR deadline often will prove unworkable. “The science, technology, regulations, and policies underpinning premarket approval and similar marketing submissions are complex, so formulating a thoughtful and focused SIR often requires more than 30 days,” the association says.

AdvaMed also makes these general recommendations (in addition to specific line-by-line comments): 

- FDA should provide a mechanism to accommodate pre-submission meetings involving more than 3-4 substantial questions; and
- FDA should create a Q-sub mechanism for discussion of patient preference, patient experience, or patient perspective input studies.

In its [comment](https://www.regulations.gov/document?D=FDA-2018-D-1774-0007&ref=fdaweb.com), Cook Group says the increase from 21 to 70 days response time for some submissions “would dramatically impact the usefulness of this process. It is not unreasonable that a company may need more than 30 days to (a) review a hold letter, (b) determine that a submission issue request is warranted, (c) prepare all the materials for such a request, including potentially proposed alternative testing plans, with protocols, and (d) prepare the actual submission itself. Thus, for the kinds of concerns that would most require this type of meeting, companies may not be able to prepare an adequate request within those 30 days, and would then face an extensive timeframe for a response from the agency during its hold time, delaying initiation of any testing or other work needed for the relevant portion of the response. The need for a 70-day review period for requests received later than 30 days after a hold is not clear.”

Finally, the Medical Imaging and Technology Alliance [says](https://www.regulations.gov/document?D=FDA-2018-D-1774-0009&ref=fdaweb.com) FDA must keep the existence and content of Q-subs confidential, subject to confidentiality provisions, including information released through Freedom of Information Act requests.