Officials at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) offered clarifications related to the Q-submission program’s evolution during a recent webinar.
The Q-submission program is intended to provide a mechanism for sponsors of medical device submissions to request early interactions with agency staff prior to reaching the submission phase. A common question to CDRH relates to the newly introduced two-tiered review timeline for goals on submission issue requests (SIRs) as pre-submissions are the only Q-submission type with set commitments and goals under the Medical Device User Fee Act’s fourth reauthorization (MDUFA IV).
CDRH director of premarket operations Joshua Nipper joined CDRH acting policy analyst Susannah Gilbert for the Q&A portion discussing changes to the Q-submission program that a May final guidance
implemented and specific situations deemed appropriate or inappropriate for industry’s use of the Q-submission program.
Gilbert gave a two-part explanation on the decision for allocating two review time goals on SIRs. The agency “wants to encourage a shorter hold time and prompt resolutions that will support the achievement of the MDUFA shared outcome goal for total time to decision” on marketing submissions and it believes that “this time will help achieve this goal.” It also aims to allow issues to be fresh in one’s mind and avoid refamiliarization when an SIR is received months after the issues were first discussed.
The final guidance expanded the program to include different types of Q-submissions, but Nipper clarified that the idea is not to have every question coming to CDRH to be a pre-submission or Q-submission. A question CDRH frequently gets is whether a pre-submission should be used for simple questions, such as what is the best way to submit two devices with the same intended use for premarket review, according to Nipper. A sponsor should float such a question to the lead reviewer or the management team dealt with in the past rather than going through the Q-submission program.
“If it’s a complicated question that we feel we’d need additional analysis or review to look at, that might be something that a reviewer is going to say, ‘I don’t have enough information to answer this by phone or even by email so please submit a pre-submission and we can discuss in further detail,’” Nipper added.
Another question raised relates to whether a sponsor can throw a least burdensome flag—a mechanism implemented
in March as a way to argue that content in a 510(k) deficiency letter is inconsistent with the least burdensome principles of the FD&C Act
—prior to the submission phase. Nipper responded by saying there are no plans to “extrapolate the least burdensome flag down to pre-submissions” or create another appeal process for pre-submissions because these provide “our best feedback at the time.”
Nipper suggests raising any least burdensome-related concern to management, though “a lot of pre-submission feedback is reviewed by management so in most cases they will be aware of the issue.”
Biocom business development manager Anthony Gonzales posed questions on how to leverage the Q-submission program for artificial intelligence (AI) companies as “it is ambiguous whether or not they would be regulated by FDA.” Gilbert and Nipper pointed to the agency’s congressional support team and 513(g) procedures on information requests regarding device classifications and applicable requirements.
Nipper further clarified, however, that the agency is in full support of pre-submissions or informational meetings for a company to present a product and request feedback on the development plan. “If the there are questions about whether or not it would be regulated, we often will bring those experts in to have some of those initial discussions,” he said. “You wouldn’t likely get a formal decision on that under the pre-submission program,” rather general suggestions or feedback. “It’s a very complicated question, but we would certainly support [using] the Q-submission program to help guide you in those questions."