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CDRH official offers advice for smoother Q-submission meetings

Posted 22 July 2021 | By Joanne S. Eglovitch 

CDRH official offers advice for smoother Q-submission meetings

A policy analyst with the US Food and Drug Administration (FDA) walked through mechanisms the medical device industry can use to request pre-submission meetings, as well as best practices for ensuring smooth reviews.
Susannah Gilbert, Q-submission program lead with the division of regulatory programs at FDA’s Center for Devices and Radiological Health (CDRH), gave the updates at a 21 July webinar sponsored by the FDA’s Small Business Regulatory Education for Industry (REdI).
Gilbert described the three common types of Q-submissions used by manufacturers, and how they differ. These review mechanisms were outlined in FDA’s final guidance on Q-submissions, but the agency still fields questions about the various Q-submission types, she said. (RELATED: FDA Finalizes Q-Submission Feedback and Meetings Guidance, Regulatory Focus, 6 May 2019)
The first category is the “presubmission program,” used to get advice before applications are submitted; this category constitutes 75% of the submission requests. The next category, representing 11% of requests, is submission issue requests (SIR) for previously submitted applications, used to discuss outstanding issues related to a marketing authorization hold letter.
The third category is a request for an informational meeting, which gives sponsors an opportunity to have interactive dialogue with the FDA to address device development topics and is outside the scope of the two other types of submissions. This category constitutes 4% of submissions.  The other type of Q-Submission interaction programs are PMA “Day 100” meetings and “Agreement and Determination Meetings”.
“The purpose of these programs can vary widely,” said Gilbert. They can be used to guide product development, help develop protocols, or help prepare a marketing submission. Yet all three “are a way to ask questions and receive feedback.”
The agency received 4,500 Q-submissions in FY 2020, an increase from the 4,200 received in FY 2019 and the 3,500 submissions received in FY 2018. The number of requests for presubmission meetings and feedback also increased to 3,305 in FY 2020 from 1,779 requests in FY 2013. The number of presubmission meetings similarly increased from 755 in FY 2013 to 1713 in FY 2020.
Different categories explained
To request feedback or a meeting, applicants must designate the review category and whether they want presubmission advice, are requesting feedback on a SIR, or want feedback on a new technology through an informational meeting.
If requesting a presubmission meeting, sponsors should limit their questions to three or four topics and ensure that these questions are “precise” and “not too broad.”
“We find that with too many different topics, it is difficult to conduct a valuable review and have a meaningful conversation. We like to stay focused on specific topic areas,” said Gilbert. Also, sponsors should request potential meeting dates and provide the regulatory history in the meeting request. The Medical Device User Fee Amendments of 2017 require FDA to grant feedback or meeting requests within 70 days.
Sponsors should ensure that the right people are at the meeting and not provide new information between the original request for feedback and the time the meeting is held, added Gilbert.
SIRs and informational meetings
Gilbert said that the goal of the SIR is to “help move the project forward to help address deficiencies.” This mechanism should not be used to address “simple clarifications” such as administrative issues related to an application. Sponsors should also specify the deficiencies they want to discuss, and this mechanism should not be used to discuss deficiency responses.
Informational meetings are different because they do not include questions for FDA to answer, but instead present information to FDA on ongoing developments for future device submissions.
The Q-submission program has evolved over time, said Gilbert. The pre-investigational device exemption (IDE) program was established in 1995 to help manufacturers get pre-submission feedback for IDEs. The pre-submission program was launched in 2013; the program was expanded in 2014 to cover other types of submissions, such as 510(k)s, premarket approval applications and pre-humanitarian device exemptions (HDEs) as “everyone saw the utility” of these programs. The Q-submission program formally launched in 2019.
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