The new article covers the aspects related to usability testing to be conducted, and also to electrical safety and electromagnetic compatibility.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to photobiomodulation (PBM) devices in the context of premarket notification (510(k)) submissions. The document is intended to provide additional clarifications regarding the existing regulatory requirements, as well as additional recommendations to be considered in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their nature, nor are intended to introduce new rules or impose new obligations, but rather to assist medical device manufacturers and other parties involved in interpreting and following the requirements PBM devices are subject to. The authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the current legislation and has been agreed with the authority in advance.
The scope of the guidance covers, inter alia, the aspects related to usability study considerations for Over-the-Counter (OTC) home use PMB devices, as well as to the electrical safety and electromagnetic compatibility (EMC).
Usability Study Considerations
According to the guidance, the parties responsible for OTC PBM devices are advised to perform three usability studies in order to support marketing submissions that are intended to:
- 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;
- Demonstrate that lay users can correctly and safely use the device after reading and following the instructions for use; and
- Assess the understanding and comprehension by lay users of the patient labeling including all indications, contraindications, warnings and precautions.
The authority additionally emphasises that in case of cold sore devices, the scope of simulated testing should cover information from a usability, label comprehension and self-selection study in order to demonstrate that the intended users will be able to use the product in a proper way without any additional assistance.
The document further highlights the key points to be taken into consideration when conducting the abovementioned studies, namely:
- Study sponsors are allowed to combine multiple studies and conduct them simultaneously, provided this is duly considered when developing a study design;
- Study participants should be representative in terms of the intended users of the device;
- The labeling for the device should be initially tested with a small group of participants and then revised if needed based on the results of such a preliminary assessment – the said procedure could be completed multiple times before conducting the main study with larger number of participants involved;
- In case of any changes to the labeling, the final version should be subject to testing in order to ensure the instructions and recommendations contained therein will be interpreted in a proper way by the intended users;
- If the labeling is comprised of multiple components and changes are made to some of them, the same changes should be incorporated in all of them;
- The most important instructions and warnings related to the safety should be placed on the box labeling in order to make it easier for intended users to observe them without the need to read the instructions for use.
The authority also encourages the parties responsible for OTC PBM devices to get in touch with the FDA in advance to discuss the key points before submitting the application itself. In such cases, a Pre-Submission pathway could be used as prescribed under the Q-submission program.
It is also important to mention that medical device manufacturers may conduct only a part of the usability studies described herein, or even abstain from conducting them at all. However, should it be the case, an appropriate justification should be provided. At the same time, for cold sore devices, this information will be mandatory, and hence, should be included in the submission.
The authority additionally emphasizes the importance of taking into consideration specific risks associated with the use of medical devices by laypersons having no proper qualification and training, as well as the use environment being the home setting. In this respect, the authority refers to separate guidance documents dedicated to the design considerations for devices intended for home use, and on medical device patient labeling.
Electrical Safety and Electromagnetic Compatibility
Apart from usability considerations, the scope of the guidance also covers the matters related to electrical safety and electromagnetic compatibility (EMC). These matters are important since PBM devices are medical electrical equipment and therefore may expose the operator and patient to hazards associated with the use of electrical energy or may fail to operate properly in the presence of electromagnetic disturbance. Thus, in order to ensure compliance with the applicable regulatory requirements, as well as overall safety and proper performance, PBM devices should undergo the respective testing. According to the recommendations provided in the guidance, such a testing should be carried out in line with the respective FDA-recognised standards, namely:
- ANSI/AAMI ES60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance;
- ANSI/AAMI IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.
Additional requirements should be applied in case of cold sore devices – in particular, performance testing should be conducted in order to validate electromagnetic compatibility and electrical safety. In particular, it is stated that compliance with the applicable standards could be demonstrated by submitting a declaration of conformity. The scope of the said declaration should cover the review of the testing results, as well as the details about testing methods used.
In summary, the present FDA guidance highlights the key points related to usability testing for OTC PBM devices, as well as the matters associated with electromagnetic compatibility. The document outlines the scope of testing to be conducted in order to validate proper performance and compliance with the respective requirements.
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