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GUIDANCE DOCUMENT

Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions Draft Guidance for Industry and Food and Drug Administration Staff January 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2022-D-3116
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document provides the FDA’s recommendations on non-clinical testing, clinical studies, and labeling to support premarket submissions for photobiomodulation (PBM) devices, also known as low level light therapy (LLLT) devices. This guidance applies to class II PBM medical devices regulated under 21 CFR 878.4810, 878.4850, 878.5400, and 890.5500. This guidance also applies to the PBM component of devices that combine a PBM device with another device(s) (e.g., electrostimulation source, mechanical massager, or ultrasound). Some light-emitting products that are intended for only general wellness use and present a low risk to the safety of users and other persons, may not be within the scope of this guidance. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of PBM device submissions.

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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-2022-D-3116.

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