FDA Strengthens Manufacturer Interactions Program: New Guidance on the Q-Submission Program

On May 29, 2025, the FDA(Food and Drug Administration) published a new version of the guidance on the Q-Submission Program, detailing the different mechanisms through which manufacturers and other interested parties can request formal interactions with the Agency in the context of regulatory processes for medical devices.

The Q-Submission Program continues to be an essential and voluntary tool to facilitate communication with the FDA throughout a device's lifecycle, allowing manufacturers to get early feedback on non-clinical studies, clinical studies, test plans, submission strategies, and other critical aspects before submitting formal regulatory submissions.

The guidance covers a variety of submission types, including:

• Pre-Submissions: formal requests for written feedback and/or meetings on submission plans (e.g. IDE, 510(k), PMA);

• Submission Issue Requests (SIRs): used to discuss strategies to resolve deficiencies identified by the FDA in ongoing submissions;

• Study Risk Determinations: FDA assessments of the risk classification of proposed clinical investigations;

• Information meetings: no feedback expected, useful for presenting new or complex devices;

• Requests for classification of accessories and interactions for innovative devices or the STeP program.

This update also presents best practices for the structure and content of Q-Submissions, including details on how to prepare requests, acceptance criteria, and expected response times. Practical examples and guidance are provided on how to effectively manage these interactions, with a view to greater predictability and regulatory efficiency.

For medical device and IVD manufacturers who want to obtain early validation of their plans and reduce risks during submission, understanding and taking advantage of this program is key.

Find out more about how to structure a robust regulatory strategy on our website.

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