Wearable medical devices are a relatively new and rapidly growing area of medical device development that may soon be the target of greater oversight by the US FDA and European Commission
The wearable technology industry is expected to generate $34 billion in global revenue by the year 2020, according to Forbes magazine. In the healthcare industry, wearable medical devices are already being used with significant results in a variety of contexts.
Consumers have access to wearable watches that monitor heart rate and blood glucose levels to collect biometric data in real-time, measure and analyze eating patterns, and some wearable medical devices are connected to the Internet of Things (IoT) transmitting patient data directly to an attending clinical physician.
From a regulatory standpoint, wearable medical devices are not directly addressed by the current medical device regulations - neither the FDA QSR in the United States nor Europe’s Medical Devices Directive (MDD) 98/42/EEC makes any reference to wearable medical devices. Still, both the FDA and the European Commission are continuously adapting their policies to reflect the existing medical device landscape, which includes addressing wearable medical devices.
What Does FDA Say About Wearable Medical Devices?
In July 2016, the FDA released a guidance document discussing policies that would allow low risk medical devices to be classified as general wellness devices. The document defines a general wellness device as a product that meets the specified criteria:
- The product is intended for only "general wellness use", as defined in the document, and
- The product presents a low risk to the safety of users and other persons
The guidance document defines the intended use of a general wellness product as:
- relating to maintaining or encouraging a general state of health or a healthy activity, or
- help to reduce the risk of impact of certain chronic diseases or conditions where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the specific disease or condition
The FDA guidance suggests that wearable medical devices such as heart rate monitors (Apple Watch) and applications like MyFitnessPal would be classified as general wellness products because they present a low risk to the intended user and they encourage a general state of health.
Still, wearable medical device products must be treated as medical devices when they begin to make claims about medical benefits such as disease prevention, treatment, mitigation or cure - but as long as they simply claim to generally improve health, many types of wearables will remain unregulated by the FDA.
What Does the European Commission Say About Wearable Medical Devices?
Under the current Medical Devices Directive (MDD) 98/42/EEC, devices that are intended to be used for a medical purpose are deemed medical devices, but it is not totally clear what constitutes as a "medical purpose" under the directive. Importantly, the MDD defines medical devices as those intended for the diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or handicap.
The new European Medical Device Regulations (EU MDR) that goes into effect May 26 of 2020 has broadened the definition of medical devices to include devices that offer a prognosis or prediction of health. This could mean that certain wearable medical devices would qualify to be regulated under the MDR if they collect biometric data that is used to inform a health prognosis about the user.
Greenlight Guru Supports Medical Device Compliance with the FDA QSR and EU MDR
If your medical device company is developing a wearable product, you may be required to establish a quality management system in compliance with FDA 21 CFR Part 820 (U.S. market) or that demonstrates conformance with ISO 13485 (international market). Greenlight Guru's medical device QMS software helps companies streamline their pathway to market approval and removes the regulatory burden for companies to focus on innovation and bringing safe devices to market faster.