Author: Ruth Black
2020 has brought many challenges to industry and regulators alike. This is primarily due to the emergency response to the COVID-19 pandemic, but also in some instances due to other regulatory transitions at play such as the European 93/42/EEC (MDD) to the new 2017/745 (MDR). For example, in countries where CE-marking is accepted as an equivalent form of conformity assessment (e.g. Australia), recent timeframes of these reviews have been particularly unpredictable. Despite this, there are still many opportunities for manufacturers to gain regulatory approval in regions supported by larger regulators that operate under a separate model for pre-market reviews.
The US market is supported by one of the largest Agencies (US FDA) and premarket regulations operate under an independent model (e.g. 510k, De-Novo, PMAs). The FDA also continues to improve transparency in its regulations by releasing an increased number of guidance.
One area which has always been somewhat cloudy is the regulation and regulatory applications of digital health. On 29 July 2020, the U.S. FDA issued a guidance document “Multiple Function Device Products: Policy and Considerations” to address this quandary.
The guidance aims to identify the principles and pre-market review practices for the FDA’s assessment of multiple function device products. Specifically, the guidance aims to clarify when and how the FDA intends to assess the impact of a device function that may not require premarket review.
What is a multiple function device?
According to the FDA guidance, products with at least one (Medical) Device function and at least one “other function” (i.e. non-device function), will fall within the definition of multiple function device products.
The term “function” is defined as a distinct purpose of the product, which could be the intended use or a subset of the intended use of the product.
The guidance document provides several examples of multiple function devices, including:
- a Transcutaneous Electrical Nerve Stimulation (TENS) device controlled by an app on a mobile platform worn by the user to treat pain. In this example, the functions under review are the Electrical Nerve Stimulation as a treatment for pain and the app used to control the level of stimulation. The app will require Bluetooth functionality of the mobile platform (i.e. Smartphone, tablet) to provide connectivity to the worn device enabling remote control of the stimulation, the Mobile platform Bluetooth transceiver and connectivity being the “other function”.
- a monitor that measures and displays vital physiological parameters (device function under review) and transmits them to an Electronic Health Records (EHR) system through the hospital network using a built-in Wi-Fi card (other function).
FDA Multiple Function Device Products: Overview of the Policy and Considerations
The FDA guidance not only provides a list of documentation requirements for premarket submission (such as labelling, architecture and design, device hazard analysis performance testing etc) for a device function under review, it also focuses attention towards “other functions”.
To assist with determining whether information about a non-regulated (other) function needs to be part of a premarket submission, the FDA has included a flow chart with decision points and considerations in relation to the impact such function may have on the safety or effectiveness of the device and other device functions. In summary:
- other function “does not impact the device function-under-review” – premarket submission for the device does not need to include documentation pertaining to the other (non-medical) function. However, the manufacturer should still conduct appropriate verification and validation testing and risk mitigation assessments.
- If the other function “could adversely impact the device function-under-review” – premarket submission for the device should include data relating to the primary function under review and appropriate documentation for that other (non-medical) function.
- If the device function-under-review could be positively impacted by the “other function” (i.e. improves, speed, efficiency) and is a benefit claimed by the manufacturer (e.g. included in the device labelling) – supporting documentation relating to the “other” function should also be included in the pre-market submission.
Furthermore, the guidance mentions that “FDA intends not to review a device function subject to an enforcement discretion policy merely because it is part of a multiple function device product”.
One other major consideration is software and cybersecurity risks of such ‘other functions’ (non-medical device component) on the device function-under-review and the concern of malicious or unintentional cyberattacks to the user. When considering cybersecurity risks the guidance recommends “some level of separation of the device function-under-review from the ‘other function(s)’ in design and implementation may be necessary to mitigate cybersecurity risks to the device function-under-review.”