The scope of the guidance covers, inter alia, the aspects related to clinical performance testing PBM devices should be subject to in order to collect necessary clinical evidence demonstrating their compliance with any and all applicable requirements in terms of safety, quality, and effectiveness. In particular, the document describes the purposes/objectives of a potential investigation, the applicable controls, inclusion and exclusion criteria to be applied, and also highlights the key points related to study endpoints and duration, as well as statistical considerations and adverse event monitoring.
Clinical Performance Testing: General Principles
According to the guidance, in vivo studies are to be conducted in order to collect additional data with respect to the actual safety and effectiveness of PBM devices, should a non-clinical evaluation appear to be insufficient to evaluate the above matters. An additional clinical investigation could also be required in case of changes to the main characteristics of a PBM device, such as indications for use or output parameters in comparison to a predicate – a similar medical device already placed on the market and used as a reference point. Thus, the authority recommends to conduct in vivo (i.e., clinical) studies to determine the safety and effectiveness for new and modified PBM devices when the device is operated by the intended user, on the target population, and is instructed in the labeling. The FDA additionally emphasizes the importance of ensuring the clinical investigation is designed in a way reflecting the intended population as closely as possible. In the case of cold sore devices, additional requirements apply – clinical data should demonstrate the healing time reduction and address the risks related to discomfort the patient can experience.
As further explained by the authority, clinical studies related to new medical devices and intended to demonstrate substantial equivalence should be carried out under the Investigational Device Exemption (IDE) framework. The FDA mentions that the products covered by the scope of the present draft guidance are considered to be non-significant risk devices, consequently, abbreviated requirements would apply. At the same time, should the device in question be intended to provide treatment in a way, different from the existing standards of care, it will be considered a significant risk device, and the respective requirements will apply. It is also stated that for the clinical investigations conducted in the US general requirements related to governing institutional review boards and informed consent will apply. However, the data deriving from clinical trials conducted abroad could also be used to support the claims made by the medical device manufacturer, provided such data meets the applicable acceptance requirements set forth by regulation 21 CFR 812.28.
The authority also mentions that “real-world data” (RWD) could be provided to support the expansion of the indication for use with respect to a medical device that has been already approved for marketing and use in the country. The need in RWD will be determined on a case-by-case basis. In particular, it is stated that if a cleared device is being used in the normal course of medical practice, an IDE would likely not be required.
The document further describes each of the investigation-related aspects in detail. According to the guidance, the objectives should be determined based on the indications for use applicable to the device. In particular, performance assessments should generally address both the desired outcome(s) (i.e., effectiveness) and potential undesired effects, to support benefit-risk analysis. Furthermore, study outcomes should be subject to evaluation based on the actual performance demonstrated by a similar medical device already placed on the market, i.e., a comparative approach should be applied.
As explained by the FDA, special controls should be applied in order to distinguish the effect of the use of the device from the background effects that are not related thereto, including the placebo effect. The authority also encourages medical device manufacturers and parties responsible for clinical trials to ensure that treatment and control assignments be blinded from the study subjects and from the investigator(s) performing the post-treatment evaluations.
The scope of the guidance also covers specific criteria to be applied in the context of study participants’ enrolment. Under the general rule, the selection of study subjects [should] include all subjects for whom a device is intended, with qualifying criteria for minimum or maximum severity of the condition to be treated, when appropriate. At the same time, the authority additionally emphasizes that some of the potential study participants would not be actually eligible for participation due to safety concerns. The factors to be taken into consideration include, inter alia, age, skin type, body side, subtype and/or severity of the disease of the disorder in question.
In summary, the present FDA guidance provides an overview of the regulatory requirements related to clinical investigations for PBM devices. The document describes the most important aspects to be considered in the context of clinical study design, as well as the way it should be conducted.
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