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USFDA Guidance: Photobiomodulation (PBM) Devices & Premarket Notification [510(k)] Submissions

Recently (12-January-2023) the US Food and Drug Administration (FDA) relaeased draft guidance on "Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions".

The term “photobiomodulation” is defined as the application of light at an irradiance that does not induce heating with the goal of altering biological activity especially which are intended for use in applications such as aesthetics, dermatology, and other general indications.

This draft guidance outlines its recommendations for non-clinical testing, clinical studies, and labeling for devices that support photobiomodulation (PBM), or low-level light therapy (LLLT).

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 mechanism of actions for PBM for different clinical indications is not fully understood whereas the outcomes are dependent on many factors such as wavelength of light, fluence, irradiance, pulsing parameters, and beam spot size.

This guidance applies to class II PBM medical devices and 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).

The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of PBM device submissions.

Click this LINK, to know more in detail about the Photobiomodulation & Premarket Submission Recommendations.


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