Managing Digital Health Regulatory Uncertainty

Uncertainty abounds when managing digital health regulatory uncertainty regarding the FDA and other international regulatory bodies. For this discussion we'll divide uncertainty into two categories, uncertainty due to a lack of knowledge about the potential regulations on the part of manufacturers and uncertainty about just what various regulatory agencies are doing - or going to do - about new and innovative products that meet the definition of a medical device.
What is a Medical Device?
Let's start with the first category; there is an astounding amount of misinformation and just plain wrong-headedness on the part of many vendors (and providers) who are outside the ranks of traditional medical device manufacturers. The first issue we need to address is the question, "What is a medical device?" Here's the legal definition of a medical device, courtesy of FDA:
A device is:

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical ac...

Source: Medical Connectivity Consulting - October 24, 2018 Category: Information Technology Authors: Tim Gee Tags: Regulatory Bibliography Standards & Regulatory Source Type: blogs