The new article addresses the matters related to modifications to photobiomodulation devices, provides definitions of the most important terms and concepts used, and also describes warnings and precautions to be included in labeling.
Table of Contents
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to photobiomodulation (PBM) devices in the context of premarket notification submissions under the 510(k) framework. Once finalized, the document will provide an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, it is important to mention that provisions of FDA guidance documents are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to assist with interpreting the ones set forth under the current regulatory framework. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance.
Changes and Modifications: Key Points
The scope of the guidance covers, inter alia, the aspects related to modifications to medical devices already placed on the market under the 510(k) premarket notification pathway. First of all, the authority states that in accordance with the applicable regulation, namely 21 CFR 807.81(a)(3), a change or modification to a device in commercial distribution “that could significantly affect the safety or effectiveness of the device” or represents “a major change or modification in the intended use of the device” requires a new 510(k). The document further outlines the scope of changes or modifications that will require a new 510(k) premarket notification to be submitted. At the same time, the authority additionally emphasizes that the list of examples provided in the guidance is non-exhaustive, so a case-by-case assessment will be required. In this respect, the authority refers to the respective guidance documents dedicated to the change-related 510(k) submissions whereby the appropriate decision-making process is described.
Changes Requiring a New Submission
As it was mentioned before, certain changes to PBM devices allowed for marketing and use would require new 510(k) premarket notification submissions due to the significant impact they are expected to have. According to the guidance, this includes the following modifications:
- Changes to the light source, circuity, or power supply of the device – according to the document, such changes are considered to be modifications in design and energy source, and are supposed to affect significantly the safety of the device.
- Change in light output or treatment regimen – as explained by the authority, such changes are considered to be modifications in design, that could affect significantly the safety and effectiveness of a medical device.
- Changing from prescription use to OTC use – such changes are considered to be significant as well since they can affect the safety and effectiveness due to the corresponding change in the intended user and use environment.
Changes that do not Require Resubmission
The document also outlines the scope of changes to PBM devices that will not require a new premarket notification to be submitted under the 510(k) framework due to the lower impact on the safety and effectiveness of a medical device. According to the guidance, the list of such changes includes:
- Cosmetic changes to the appearance of the device;
- Changes to the labeling that do not affect the intended use, indications for use, or conditions of use.
Terms and Definitions
Apart from the additional clarifications on regulatory requirements related to changes and modifications to PBM devices, the guidance also provides definitions of the most important terms and concepts used in this respect. The terms addressed in the document include, inter alia, the following ones:
- Fluence – light energy received by a surface per unit area;
- Irradiance – light power received by a surface per unit area;
- PBM – Photobiomodulation, also known as low level light therapy (LLLT), a therapeutic technique that uses low-energy light to alter the function of the body.
- Wavelength – the distance between two successive wave crests; determines the colour of the light in the visible spectrum.
In order to assist medical device manufacturers and other parties involved in operations with PBM devices, the authority also provides examples of labeling to be used for products of this type. In particular, this section of the guidance outlines the key elements to be included in the labeling in order to communicate to potential users vitally important information they should consider when using the device for its intended purpose. According to the guidance, labeling should include:
- Warnings, such as “The long-term effects of prolonged use of non-thermal laser exposure are unknown” or “Safety of non-thermal lasers for use during pregnancy has not been established”.
- Precautions, such as “To eliminate any possible danger to the eyes, safety glasses must be worn by the patient during treatment”, “Use only with accessories recommended by manufacturer”, or “Avoid the ingress of any liquid”.
In summary, the present FDA draft guidance describes in detail the regulatory requirements for PBM devices set forth under the existing framework. The document explains the approach to be applied with respect to changes and modifications to PBM devices already approved for marketing and use depending on the impact such changes are expected to cause on the safety and effectiveness.
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