FDA updates Q-Sub guidance ahead of new Pre-Sub draft guidance

The US Food and Drug Administration has updated its final guidance on its Q-Submission program in line with changes negotiated in the recent medical device user fee agreement addressing issues surrounding Pre-Submissions while the agency develops a standalone draft guidance on the topic.

The most recent Medical Device User Fee Amendment (MDUFA V) included a number of new performance goals for FDA. Part of those updated performance goals includes new requirements for how FDA provides feedback through the Pre-Submission (Pre-Sub) process, which is part of the Q-Sub program.

“To address a MDUFA V commitment, the FDA intends to issue a revised draft guidance including information on when informal communication is appropriate instead of a Pre-Sub, among other updates,” said FDA. “While this new draft guidance is being developed, the FDA is making minor procedural updates and clarifications on the mechanisms that stakeholders can use to request feedback.”

The updated guidance gives examples of common review topics and questions for a Pre-Sub request, timing considerations for multiple submissions, administrative content to include in Q-Subs to facilitate FDA review, Q-Sub meeting minutes format and submission process, and existing mechanisms to obtain FDA feedback outside of the Q-Sub Program.

One of the most significant updates in the guidance is the ability for sponsors to get Pre-Sub feedback for predetermined change control plans (PCCP). While FDA has already authorized a number of artificial intelligence/ machine learning products, it only recently published a PCCP guidance after Congress passed legislation last year giving the agency explicit authority to enable PCCPs.

In the guidance, FDA recommends that sponsors who want to use PCCPs to use the Pre-Sub process to get agency feedback. While the agency has the authority to authorize or clear PCCP products, there are still a lot of unknowns that can be hashed out with sponsors before they get too deep into their product development and premarket submission process.

“FDA may require that a PCCP include labeling for safe and effective use of a device as such device changes pursuant to such plan, notification requirements if the device does not function as intended pursuant to such plan, and performance requirements for changes made under the plan,” the guidance states. “FDA encourages the use of a Pre-Sub as it provides an opportunity to work proactively with the FDA in the development of the PCCP, which helps to streamline the premarket review.”

In recent years FDA has emphasized the development of Medical Device Development Tools (MDDT). In the updated guidance, the agency says while such tools were previously tracked with Informational Meeting Q-Submissions, moving forward they will be tracked with a Universal Tracking Number (UTN), and they should be identified as ‘MDDT’ in the submission cover letter.

The guidance also addresses early conversations related to emergency use authorizations (EUAs).

“There is a separate pre-EUA process that should be utilized for discussions about EUAs, which is distinct from the Pre-Submission process,” the guidance states. “Additional information regarding EUAs and Pre-EUAs can be found in the guidance entitled ‘Emergency Use Authorization of Medical Products and Related Authorities.’”

FDA updates Q-Sub guidance ahead of new Pre-Sub draft guidance

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