Devices

Guide on 510(k) Submissions for Photobiomodulation Devices

FDA has released a draft guidance entitled “Photobiomodulation (PBM) Devices — Premarket Notification 510(k) Submissions.” The document provides draft recommendations for 510(k) submissions for PBM devices (also known as low level light therapy devices), which are intended for use in applications such as esthetics, dermatology, and other general indications. Such devices are designed to deliver a non-heating dose of light energy into the body to provide clinical benefit to the patient, according to the guidance.

The guidance defines PBM as the “application of light at an irradiance that does not induce heating with the goal of altering biological activity.” It says a PBM device may use a light source that is coherent (laser) or non-coherent (filtered broadband lamps or light-emitting diodes), or a combination of both. “PBM is commonly provided by using light in the visible and near infrared spectral ranges, but PBM effects are not exclusive to these ranges,” it says. “PBM therapy is provided at a much lower fluence and irradiance compared to ablative or coagulating light devices such as those using high power lasers or intense pulsed light (IPL) sources. The mechanism of actions for PBM for different clinical indications is not fully understood. Outcomes are dependent on many factors such as wavelength of light, fluence, irradiance, pulsing parameters, and beam spot size.”

To support a marketing submission for an over-the-counter PBM device, the document recommends that firms perform three usability studies to 1) demonstrate that lay users can correctly self-select themselves as being appropriate users of the device for the stated indication by reading the box labeling, 2) demonstrate that lay users can correctly and safely use the device after reading and following the instructions for use, and 3) assess the understanding and comprehension by lay users of the patient labeling including all indications, contraindications, warnings and precautions.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome