Device makers seek flexibility, clarity in Q-sub electronic submission guidance

Medtech industry stakeholders said they want greater clarity and flexibility in the US Food and Drug Administration’s (FDA) recent draft guidance on submitting questions electronically to the agency under its Q-Submission program.

In May, the Center for Devices and Radiological Health (CDRH) published a draft guidance on FDA's expectations for medtech sponsors who submit pre-submissions (pre-subs) electronically to regulators as part of the agency's Q-submission program.

Several stakeholders have responded to the draft guidance by asking for more clarity in the terminology used and more flexibility in the number of questions that sponsors can ask in a single request. They furthermore note that only pre-submission requests are required to be addressed electronically.

The medtech lobby group AdvaMed said the electronic submission template (eSTAR) templates covered in the guidance should maintain the same flexibility afforded to electronic copy (eCopy) submissions. The group said limiting the number of questions could inadvertently increase the regulatory burden. It noted that the current pre-sub eSTAR template limits the number of discussion topics to four and a maximum of 10 questions, which is not the case for eCopy submissions and is not based on existing regulations or statute.

"A restrictive and inflexible approach to Pre-Sub eSTAR content and questions could lead to fragmented communications requiring multiple Pre-Submissions for what would otherwise be a single comprehensive submission under the eCopy program, particularly for complex or novel medical technologies that may require multi-faceted feedback," said AdvaMed. "While the FDA’s guidance on the Q-Submission Program recommends limiting Pre-Subs to four topics, this is presented as a best practice—not a requirement.

"Enforcing such a recommendation through the design of the eSTAR template effectively converts a non-binding suggestion in guidance into a de facto requirement, which is inappropriate and inconsistent with longstanding practice and FDA’s good guidance practice regulation," the group added.

AdvaMed stated that the guidance omits many technical issues that sponsors should be aware of when using the eSTAR template to submit pre-submission questions, such as what file types it will accept and their maximum size. The group also noted that while the technical information may be available from other CDRH resources, it wants all the relevant information to be included in the guidance so that it can serve as a more comprehensive reference tool.

The draft guidance states that all pre-submission requests must be submitted electronically unless the sponsor is given a waiver, but the agency also states that it can't foresee a scenario where it would grant a waiver. AdvaMed said that it wants FDA to add language stating that it will work with sponsors if they need a waiver and describe the process for requesting a waiver.

AdvaMed also noted that while the guidance states it is for electronic Q-sub interactions and currently only pre-submission interactions that are a part of the Q-sub program are permitted to be used in this way. The group noted that the recommendations and discussion in the draft guidance only apply to pre-submission discussions and urged the agency to change the title of the guidance to reflect that.

"The repeated references to Q-Subs implies a broader applicability of the guidance to eSTAR templates that do not exist yet," said AdvaMed.

"Templates for other Q-Submission types are not currently available, and we do not think it appropriate to preemptively publish recommendations in guidance for eSTAR templates that do not exist," the group added. "As additional Q-Sub templates are developed and released for voluntary use, there may be submission-specific considerations and recommendations."

The Medical Device Manufacturers Association (MDMA) also commented on the guidance and echoed that the guidance may apply to other Q-sub types, beyond pre-submissions, in the future, and asked the agency to detail the transition process to using electronic templates for those types of Q-sub requests.

"Similar to the implementation approach used for 510(k) and De Novo, we suggest a draft and final guidance process," said MDMA. "This could be accomplished via Select Updates to the guidance as new Q-Sub types are added.

"Each finalized update should establish an appropriate transition period to allow companies time to prepare and adjust internal systems accordingly, facilitating smoother adoption and mitigate disruption," the group added.

Furthermore, MDMA wants the terminology used in the guidance to be clearer. Specifically, it said the distinction between eSTAR and PreStar, as they are currently stated in the guidance, is unclear.

"The FDA currently maintains three eSTAR templates: one for non-IVDs, one for IVDs, and one for Q-subs," said MDMA. "The first two are called eSTAR, while the third is called PreSTAR.

"The definition of PreSTAR should be expanded and clarified, the definition of eSTAR should cross-reference it, and the guidance should use the term PreSTAR throughout when referring to the electronic submission template to be used for Q-Subs," the group added.

MDMA asked FDA to include existing communication channels, such as the CDRH Collaboration Portal, in the guidance so that sponsors can submit updated eSTAR requests and their progress.

Finally, MDMA noted that the draft guidance requires non-US citizens to be identified for all meetings with FDA, which has not been required in the past and is not part of the current PreSTAR template. The group said the requirement should only apply to in-person meetings; otherwise, it would be too burdensome for international participants to meet with regulators virtually.

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Device makers seek flexibility, clarity in Q-sub electronic submission guidance

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