Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2024-05584 · Docket No. FDA-2024-D-0664

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating and/or Cooling.” FDA is issuing this draft guidance document to describe relevant information that should be provided in premarket submissions to support the evaluation of thermal effects of medical devices that produce local, regional, and/or systemic changes in tissue temperature ( i.e., heating and/or cooling) due to their use. The recommendations in this draft guidance reflect current review practices and are intended to promote consistency and facilitate efficient review of thermal effects data in premarket submissions for these devices. This draft guidance is not final nor is it for implementation at this time.

Dates

Submit either electronic or written comments on the draft guidance by May 14, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

Supplementary Information

I. Background When a change in tissue temperature occurs because of device heating and/or cooling, there is a potential for adverse health effects, such as tissue damage or a negative impact on physiological functions. This draft guidance provides FDA's recommendations for evaluation of thermal effects for devices that produce changes in tissue temperature (heating and/or cooling) as an intended or unintended consequence of device use. The draft guidance describes when experimental methods ( i.e., phantom, ex vivo tissue, and/or in vivo tissue models), computational methods, and/or clinical studies may be appropriate to assess thermal effects. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating and/or Cooling.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic copy of “Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00022002 and complete title to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in the following table have been approved by OMB: 21 CFR part or guidance Topic OMB control No. 807, subpart E Premarket notification 0910-0120 814, subparts A through E Premarket approval 0910-0231 814, subpart H Humanitarian Use Devices; Humanitarian Device Exemption 0910-0332 812 Investigational Device Exemption 0910-0078 860, subpart D De Novo classification process 0910-0844 “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” Q-submissions and Early Payor Feedback Request Programs for Medical Devices 0910-0756 800, 801, 809, and 830 Medical Device Labeling Regulations; Unique Device Identification 0910-0485 Dated: March 12, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-05584 Filed 3-14-24; 8:45 am]