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Digital platforms for wearables can serve both medical and non-medical purposes. But, when software technology helps the wearer or medical professionals identify and track information in support the diagnosis or treatment of a disease, that software is considered a medical device and is subject to FDA authority including submission and approval via 510(k) or another appropriate submission. FDA has created four risk categories, level 1 being the lowest and 4 being the highest based on the type of information assessed and how pertinent it is to the maintenance of health. So, a fitness tracker that is helping the wearer log miles may not be considered a device at all, whereas a watch with an EKG monitor would be considered a class 4.

FDA’s Digital Health Software Precertification Pilot Program is still on-going as part of the Digital Health Innovation Action Plan. Additionally, draft guidance released in 2018 that discusses FDA’s intent to review devices that include multiple functions, some of which would not be regulated as a device, ie – a watch with a fitness tracker and an EKG remains unfinalized.

Even so, the market is competitive and rapidly advancing. Here are three important considerations to stay ahead of the competition:


Is there a predicate device for your wearable technology? If so, this will make the process of FDA approval for yours significantly streamlined.


Have you ensured data privacy? Though not protected in the same way as HIPAA, FDA will want to see your data protection plan, and so will your consumers.


For devices performing multiple software functions, have all potential adverse impacts between been addressed?

With rapid advancements in technology, including use of artificial intelligence, it is imperative to understand and mitigate your FDA regulatory risk. EAS Consulting Group experts help with regulatory research, compliance with data integrity and complete and accurate filing of all regulatory submissions and applications including 510(k), De Novo and PMAs. Stay ahead of the curve and the competition. Contact EAS today to discuss your regulatory challenges and learn more about our many trusted solutions.

Posted in Medical Devices.