The U.S. Food and Drug Administration (FDA) recently updated two guidance documents applicable to wearable devices and guidance for clinical decision support tools, continuing the agency’s efforts to ease regulatory hurdles for digital health tools and potentially the use of artificial intelligence. The updates expand the type of digital health tools, including certain general wellness wearable devices and clinical decision support software, that are either exempt from medical device requirements or will be subject to enforcement discretion by FDA.
Key Takeaways
The key takeaways for industry to consider include the following:
- Software functions intended primarily for maintaining or encouraging healthy lifestyles will not likely be regulated as medical devices in and of themselves. However, once such functions begin providing functionality for clinical management or are intended to treat a disease or condition, then the software risks classification as a device.
- Clinical decision support tools that analyze patterns or signals are generally regulated as a device while tools that measure physiological parameters that are not specifically intended or marketed for a purpose identified in the device definition are not medical devices.
- FDA has indicated it intends to exercise enforcement discretion for software functions that provide only a single recommendation intended for the purpose of supporting or providing recommendations to a healthcare professional about prevention, diagnosis, or treatment of a disease or condition.
- FDA is developing a database to track wearable medical devices, including those with sensor-based digital health technology referred to as sDHT. These sDHT devices are generally subject to premarket notification requirements.