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 "Navigating FDA's Final Mobile App Guidelines: The Good, The Bad, The Unanswered."
Following is an excerpt:
Well, the FDA has finally released its final guidance on medical mobile apps to offer a clearer definition of a medical device app and what they plan to do with those apps that fall into that gray space between just an app and a medical device.
The other main area of concern may be in the app store. Bradley Merrill Thompson, a Member of the Firm at Epstein Becker & Green, P.C where he leads the Medical Device Regulatory Practice, says that lately the Federal Trade Commission (FTC) has also been making noise about focusing on health apps and they have jurisdiction over all apps—whether related to health or not.
Thompson adds that the FDA also cares passionately about labeling and instructions for use and the summary at the point of purchase is a very key element for creating the intended use of the product.
Thompson believes that this guidance is actually the least helpful to pharma companies since it fails to address clinical decision support (CDS) software, which the FDA is supposed to include in its full report on Health IT, which is due to Congress by January 2014.
Thompson, however, says that the FDA is legally required to include that statement about the recommendations being nonbinding on every single guidance document. Consequently, for all practical purposes, the industry can rely on the guidance.
"That said, the FDA can change its mind, and they specifically left open the possibility, but doing that would mean first revising the guidance document by going through the rather elaborate notice and comment process," says Thompson. "They would not do it by surprise nor would they do it retrospectively. Everyone would get considerable advance warning."
