Is the Food and Drug Administration planning a more constructive role in the creation, development and regulation of medical devices?
It would appear so.
The FDA has recently posted statements on its website acknowledging the key innovations and impact newly-developed devices are having on patient health.
It noted, “patients and consumers can use digital health to better manage and track their wellness related activities.” It singled out smartphones, social networks and Internet applications as effective ways to monitor our health and gain greater access to health information.
The FDA sees its role expanding into medical devices. “Many medical devices now have the ability to connect and communicate with other devices or systems. Devices that are already FDA -approved or cleared are being updated to add digital features.”
Here are the areas FDA cited as likely to get their attention in the months ahead:
- Wireless Medical Devices
- Mobile medical apps
- Health IT
- Medical Device Data Systems
- Medical device Interoperability
- Software as a Medical Device (SaMD)
- General Wellness
In a related development, FDA Commissioner Scott Gottlieb, M.D. made a major announcement on advancing new digital health policies. “Our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation,” he noted.
Among the FDA’s recent initiatives:
- Digital Health Innovation Action Plan
- Clinical and Patient Decision Support Software
- Changes to Existing Medical Software Policies
- General Wellness and Mobile Applications
According to the FDA Commissioner: “We’re saying that many of these products no longer qualify as medical devices that would be subject to FDA oversight.”