Two Medical Device Draft Guidances Detail Thermal Effects, Q-Submission Process

The FDA’s latest two draft guidances on medical devices address the ways in which submitters can request interactions with the agency and evaluating the thermal effects of devices that heat or cool tissue.

The first, a five page draft guidance entitled “Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating and/or Cooling,” includes recommendations that “promote consistency and facilitate efficient review of thermal effects data in premarket submissions for these devices,” according to the Federal Register notice.

The agency also issued “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” which provides an overview of how submitters can request interactions with the FDA, including written feedback and/or a meeting regarding medical device applications, and helps submitters identify whether an applicant’s question is most appropriate for informal communication instead of a Pre-Submission.

Comments on both guidances are due by May 14.

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