As technology advances, more and more medical devices are being engineered with multiple functions. According to the FDA, any product that has at least one medical device function and one non-device function is considered a “multiple function device product”. At the end of July, the FDA finalized an April 2018 draft guidance that clarifies how the agency will assess the impact of the non-device functions of a product.
The draft guidance gives several examples of multiple function device products, one being a transcutaneous electrical nerve stimulation (TENS) device worn by a user to treat pain that is controlled by an app on a mobile platform. In this example, the device functions are the electrical nerve stimulation as a pain treatment and the app used to control the level of stimulation. The non-device function of the product is the mobile platform Bluetooth transceiver and connectivity. According to the guidance, the FDA requires that manufacturers determine if a non-device function impacts the safety or effectiveness of the device.1
Included in the guidance document are detailed considerations to assess a device’s “other functions” and the role they play in the safety and effectiveness of the device. At a high-level, the agency explains that if a manufacturer determines a non-device function does not impact the safety/effectiveness of the device, the impact assessment and justification must be properly documented per the manufacturer’s QMS. If the other function does have an impact on the safety/effectiveness of the device, it is important to determine if it is a negative impact (i.e. increased risk) or a positive impact (i.e. increased functionality of the device which the sponsor intends to include in the labeling). In either scenario, the appropriate documentation for the non-device function must be included with the premarket submission for the overall device.2
The guidance further goes on to clarify that all impact assessments, whether negative, positive, or no impact, must be documented as part of the device’s design validation. In addition to considerations for impact assessments, labeling considerations and recommendations on device hazard analysis and performance testing are included in the guidance. As the science for medical devices continues to advance, you can expect to see more multiple function device products hit the market. If you are a manufacturer of a device with multiple functions, EMMA International can help you navigate the regulatory landscape – give us a call at 248-987-4497 or email firstname.lastname@example.org.
1Oakes, RAPS (July 2020) FDA Issues Final Guidance on Multiple Function Device Products retrieved on 08/02/2020 from: https://www.raps.org/news-and-articles/news-articles/2020/7/fda-issues-final-guidance-on-multiple-function-dev?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=Devices%20Monthly%20July%202020
2FDA (July 2020) Multiple Function Device Products: Policy and Considerations retrieved on 08/02/2020 from: https://www.fda.gov/media/112671/download