Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practices, in the Washington, DC, office, wrote an article titled “Three Reasons FDA’s Enforcement Helps Mobile Health.”
Following is an excerpt:
As MobiHealthNews reported earlier, this week FDA sent an enforcement letter to the developer of a urinalysis app. This might sound weird, but I believe that’s good news for the mobile health industry.
Full disclosure, I may have played a part in FDA’s decision to send that letter. Over the last several months, I’ve had four occasions to talk about the app publicly, including:
- A March editorial on the Medical Device and Diagnostic Industry (MDDI) websitein which I began the public discussion by arguing the app required FDA compliance, but had none. Indeed, at the time, the manufacturer was claiming that the app wasn’t even a medical device.