Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions Draft Guidance for Industry and Food and Drug Administration Staff January 2023
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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This draft guidance document provides the FDA’s recommendations on non-clinical testing, clinical studies, and labeling to support premarket submissions for photobiomodulation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.
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:
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.