The document discusses the FDA's guidance on regulating multiple function medical device products. The guidance clarifies that any product with at least one medical device function and one non-device function is considered a multiple function device. It provides examples, such as a TENS device controlled by a mobile app, where the device functions are pain treatment and app control, and the non-device function is the phone's Bluetooth. The guidance states manufacturers must assess if non-device functions impact safety or effectiveness and document this. It also provides considerations for assessing non-device functions and their role in a device's safety and effectiveness.

1. Multiple Function Medical Device Products
By: Madison Wheeler
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end of July, the FDA finalized an April 2018 draft guidance that clarifies how the agency will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The draft guidance gives several examples of multiple function device products, one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 animpact 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 canhelp you navigate the regulatory landscape - give us a call at 248-987-4497 or
email info@emmainternational.com.
1 Oakes, RAPS (July 2020) FDA Issues Final Guidanceon MultipleFunction 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
2 FDA (July 2020) MultipleFunction Device Products:Policy and Considerations retrieved on 08/02/2020 from:
https://www.fda.gov/media/112671/download