Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in BioWorld, in “FDA’s Tweak of Mobile Medical Apps Guidance Introduces Transparency Requirement,” by Mark McCarty. (Read the full version – subscription required.)
Following is an excerpt:
The U.S. FDA’s finalized guidance for clinical decision support (CDS) software was not an entirely isolated policy change inasmuch as there were several other guidances that were edited and reissued two days after the CDS final was published. One of these is the guidance for device software functions and mobile medical apps, which now encodes a transparency requirement as seen in the CDS guidance, a change that may represent a hazard for the unwary medical software developer. …
Brad Thompson of Epstein Becker & Green PC said these changes are not the minor adjustments the FDA claimed they were, arguing that the revisions have “completely removed” a category of enforcement discretion.