The definition of a medical device has withstood the test of time and has not wavered with changes. So why should that change now with the technology moving to mobile apps? It's not. It's a case of not seeing the forest through the trees.
The FDA has had oversight of software for medical devices for over four decades. These have included the software which operates a device and displays data to inform providers and patients, such as external monitor of a pace maker.
So why are there many concerns? Some see the categories FDA listed in their guidance as an effort to expand FDAs reach. In addition to traditional devices they will focus to regulate and distinct category they will not regulate (e.g. administrative systems), they have included a third category in which they will "use discretion to regulate".
Though this third category seems like a soft decision and expanded scope, it reflects: the fast pace of science & technology redefining health diagnosis and treatment, the risk/benefit of regulatory science, and the need to work through the details to identify which agency will take the lead to protect the public while promoting innovation.
The reality is with Medical Devices User Fee Act III (MDUFA III) and FDA's vision for patients in the USA to be first to have access to safe and effective medical devices, they are heads down and busy. From internal process, and enabling feasibility studies to come back to the US, while building a robust post market surveillance to enable shorter data gathering in pre-market to get products to patients FDA is not in the position to take on the fast pace of HIT for the sake of "expanding their reach".
The blunt truth is FDA is too busy to worry about apps that help people manage their health and encourage them to live healthy lifestyles.
Realistically FDA is not the only agency that enforces 'truth in advertising' to protect the public, and least of your worries, if you're a mHealth developer.
Before worrying about FDA's 'discretion to regulate', first check out the privacy and security enforcement under "breach notification" by Federal Trade Commission and The Office of Civil Rights.
Then check with your lawyer if your products claim causes a false positive or false negative, i.e. a patient delays seeing a doctor negatively impacting their health or breach of information. How vulnerable are you to civil lawsuits?
What mHealth developers should be concerned with more...is privacy, security and the quality of their apps doing what they advertise. These are enforced by FTC and HHS Office of Civil Rights.
Stay tuned for our ClearRoadmap mHealth webinars and checklist, which can help you ensure you are dotting your regulatory "i's" and crossing your regulatory "t's"!
-- Vizma Carver, Founder and CEO, Carver Global Health Group