Bradley Merrill Thomson, a Member of the Firm in the Healthy Care and Life Sciences practice, in the Washington, DC, office, was quoted in a blog titled, "Release 2.0 — Peering into the Future of mHealth Through the Eyes of Last Week's FDA Draft Guidance."
Following is an excerpt:
Although the issuance of draft guidance for mobile medical applications by the FDA on July 19th came as a surprise to many, experts close to the field have sensed that this summer would prove to be an important and pivotal period for the mHealth regulatory scheme.
In fact, the independent mHealth Regulatory Coalition has been working steadily and in parallel with the FDA to issue their own draft guidance recommendations, while Bradley Thompson, a medical device attorney and regulatory expert with Epstein Becker Green has been publicly sharing his analysis and predictions regarding mHealth regulation for quite some time ?...
"The problem is that this guidance doesn't explain how to determine whether an app meets the medical device definition in areas where questions remain about intended use. We need more clarity as to what types of claims a company can make about health and wellness that also implicate a disease before we can determine whether the app needs to be regulated or not," said Thompson ?...
As Mr. Thompson states the point is likely moot, since regulatory requirements are by definition not optional. "The FDA can't treat mHealth regulation like a Good Housekeeping Seal of Approval where certain apps get an extra marketing bonus if they go and get approval. The mandate must apply to everyone or no one when it comes to technology that performs the same way, and do so uniformly, regulating all categories of products within the prescribed high risk category equally, albeit with a lighter touch than for, say, pharmaceuticals."
