The FDA has issued guidance on submitting 510(k) applications for photobiomodulation (PBM) devices, also known as LLLTs. The products deliver non-heating doses of light energy to patients, often for aesthetic and dermatological procedures. Like other light therapies, PBM devices use coherent light sources, also known as lasers; non-coherent light sources such as light emitting diodes (LED); or a combination of two types of light sources. However, unlike other types of products, they usually do not carry the same level of risk.
“PBM therapy is delivered with much lower exposure and radiation compared to ablative or coagulation light devices such as high-power lasers or intense pulsed light (IPL) sources,” the FDA explains in the guidance. “The mechanism of action of PBM for various clinical indications is not fully understood. Results depend on many factors such as light wavelength, flux, irradiance, pulse parameters and beam spot size.”
The FDA lists in the guidance seven types of Class II PBM products that may fall under its regulatory jurisdiction, where sponsors must submit a premarket application to market them. These include certain laser surgical instruments, wrinkle and fat reduction devices, cold treatments, and non-heat devices to help treat pain.
The agency notes that products that contain PBM components, such as products for electrostimulation, mechanical massage, and ultrasound, may also require premarket administration. However, light-emitting devices that are only intended to be used as general health products and pose a low level of risk to users are not considered within the scope of the draft guidance.
The guidance addresses several issues, such as what to consider when submitting a premarket submission for a PBM product.
The guidance covers one of the key areas of how sponsors can adequately compare sponsors’ new products to the predicate product in the 510(k) application.
Generally, when a 510(k) is submitted, the sponsor must describe how the product is similar to and different from the predicate product. To address the issue, the guide includes a sample chart of what features a patron should look for when comparing products.
The guidance also provides guidance on providing reprocessing instructions and how the sponsor should present the limitations and safety profile of the PBM device in its labeling. The FDA notes, however, that if the device is not intended for human use, it does not need to have directions directed at specific people, although it must have relevant information for healthcare providers to use the product. properly.
The guideline also addresses the biocompatibility of such devices.
In recent years, the FDA has increased its focus on identifying potential biocompatibility issues with medical devices. In the draft guidance, the agency asks PBM device sponsors to either provide biocompatibility data from the predicate device or additional data to demonstrate that they have performed their due diligence to identify potential biocompatibility issues.
“You must determine the biocompatibility of all patient contact materials in your device,” the FDA said. “If your device is identical in composition and processing methods to a PBM device with a history of successful use, you may refer to previous test experience or literature as appropriate. For some device materials, it may be appropriate to provide a reference to either a recognized consent standard or a letter of authorization (LOA) for the device master file (MAF).’
“If you are unable to identify a legitimate marketed predicate device with the same site/duration of contact and intended use that uses the same materials as your device, we recommend that you perform and provide a biocompatibility risk assessment,” the agency added. “The assessment should explain the relationship between identified biocompatibility risks, information available to mitigate identified risks, and identify existing knowledge gaps. You must then disclose any biocompatibility testing or other assessments that have been carried out to mitigate any remaining risks.’
The guidance addresses other topics that sponsors should consider in their premarket submissions, including software performance, usability studies, electrical and thermal safety, and clinical performance testing.
While the FDA addresses a wide range of PBM devices in the guidance, the agency pays considerable attention to devices used to treat cold sores.
For example, the guidance states that the labeling of cryotherapy devices should direct end users to contact the manufacturer and MedWatch, the FDA’s adverse event reporting system, if they experience an adverse event. It should also include information specific to the intended patient population and treatment regimen. When recycling cold sore PBM devices, the agency states that cleaning and disinfection instructions for the devices must be validated before reuse.
Generally, the FDA proposes that over-the-counter PBM devices must undergo three usability studies, including to demonstrate that ordinary users can correctly determine that they are the intended patient population, can use the product correctly and safely, and understand the limitations. the product from the label. The agency recommends that PBMs used to treat colds go one step further.
“Note that simulated use testing for cryodevices should include information from usability, label comprehension, and self-selection studies to demonstrate that the device can be used by the intended patient population without any assistance,” the guidance states.
Interested parties may comment on the draft guidance at www.regualtions.gov in the No docket. FDA-2022-D-3116 by March 13.
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