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GUIDANCE DOCUMENT

Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling Draft Guidance for Industry and Food and Drug Administration Staff March 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-0664
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document provides the FDA’s recommendations on testing to assess thermal effects of medical devices. This guidance applies to devices that produce tissue temperature changes (i.e., heating and/or cooling) as an intended or unintended consequence of device use. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of thermal effects data in submissions for these devices.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-0664.

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