Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Readers Weigh In: The FDA Should Regulate Mobile Medical Apps."
Following is an excerpt:
It's important to know that the discussion about regulating apps doesn't apply to all health and wellness apps. The FDA is only concerned with apps that "transform a mobile device into a medical device already regulated by the FDA" or that can be used "as an accessory to a medical device already regulated by the FDA." They've termed this group of apps "mobile medical apps." ?...
Opponents worry that FDA final guidance will put a damper on the abundant development of medical apps the last few years have seen, stifling the industry.
But remember, regulation has already been happening. In a recent MobiHealthNews article, Bradley Merrill Thompson, an attorney specializing in FDA regulatory issues, clarifies this point: FDA final guidance will not change whether or not medical apps are subject to regulation — they already are. Final guidance will simply clarify and streamline the FDA's regulatory guidelines and processes. ?...
In fact—and maybe most importantly—the FDA has indicated that they don't want to regulate all medical apps that meet the definition of a device. Final guidance will clearly outline which apps will not be subject to approval requirements. That's why stakeholders such as the companies of the mHealth Regulatory Coalition are calling final guidance "deregulatory."
