Stakeholders want more early FDA communication options, shorter Q-Sub response timelines

Industry stakeholders are asking the US Food and Drug Administration (FDA) to provide more details on how informal communications can be used, expand the use of a pre-submission template, and to shorten key timelines in the agency’s Q-Submission (Q-Sub) draft guidance.

In March, the FDA published a draft guidance that clarified how it plans to conduct Q-Sub meetings with medtech sponsors and ensured a more consistent use of the process. Th process encompasses formal communication through Pre-Submission and Submission Issue Requests (SIRs) to help sponsors get early feedback on product development and marketing submissions.

Several stakeholders wrote to FDA before the 14 May comment deadline asking for significant changes to the draft that would give sponsors more options for early discussions with regulators and reduce administrative burdens. In their feedback, industry lobby group AdvaMed noted that the agency has stated that Q-Sub requests have put increasing burdens on its resources and asked it to expand the use of other communication options, such as interactive reviews, to alleviate the need for Q-Sub requests.

“While [the number of Q-Sub requests] 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,” said AdvaMed. “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 noted that FDA’s communications guidance states that interactive reviews may be used at the agency’s discretion for Pre-Sub meetings and asked it to allow expanded use of such tools.

“We recommend the guidance include additional examples illustrating how informal communications can be used in lieu of Pre-Subs and SIRs,” said the group. “These additional examples will help ensure FDA review staff and industry can consistently and mutually distinguish between the appropriate use of the Pre-Sub and SIR programs and the appropriate use of other means of communicating and receiving feedback from FDA.”

AdvaMed also asked FDA to allow greater use of the early submission version of its electronic submission template and resource (eSTAR) known as PreSTAR used for Pre-Sub applications. Like eSTAR, PreSTAR includes features that are intended to help bring more consistency and efficiency to the premarket review process, but the group says there are certain features that currently limit its use.

AdvaMed said that the PreSTAR template limits the number of topics discussed in the Pre-Sub application to four, which it said seems related to non-binding recommendations in set in guidance. In general, the group said it may seem like a good idea to limit the topics to allow for more focused discussions but argued it also mandates a requirement that isn’t based on statute.

“We respectfully request [the Center for Devices and Radiological Health (CDRH)] assess the PreSTAR and eSTAR templates for all available submission types and ensure the templates do not implement recommendations in guidance as submission requirements,” said AdvaMed. “The eSTAR templates should allow for the flexibility necessary for submitters to offer alternative approaches, consistent with the least burdensome principles.”

“We also request CDRH allow for a comment period when implementing updates to eSTAR and PreSTAR templates before issuing the updated template for use,” it added. “Such an approach will ensure that eSTAR templates are not inadvertently requiring content that may otherwise be addressed by an alternative approach.”

Emergo, a medtech consulting group, also commented on the draft guidance and asked FDA to significantly shorten several proposed timelines to make the Q-Sub process more efficient and less burdensome for everyone involved. The group said FDA should prioritize SIR applications and asked the agency to try to respond within 21 days of a submission. It argued that sometimes application processes may take longer because companies need more time to research their response to the agency, and companies may face other unexpected issues that delay their SIR requests, which eat up the time they have to respond to FDA.

“This is not least burdensome to the FDA or to industry,” said Emergo. “Therefore, we recommend that all SIR responses from the FDA be made with 21 days. Alternatively, the FDA could instead state that if there is an SIR for a submission, the response timeline is extended by the period of time that it takes the FDA to hold the meeting.”

Similarly, Emergo recommended FDA shorten the timeline to respond for Pre-sub meetings where only a written response is needed and responses to Study Risk Determinations to 30 days. It also argued that since Informational Meetings typically don’t include FDA feedback, there is no reason they should take longer to respond to than scheduling a Pre-Sub meeting, which is 70 days.

Draft guidance comments

Stakeholders want more early FDA communication options, shorter Q-Sub response timelines

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