Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Dive, in “Digital Health Advice from FDA Amid Coronavirus Leaves More Questions Than Answers,” by Greg Slabodkin.
Following is an excerpt:
FDA on Thursday issued a communication in response to the novel coronavirus outbreak emphasizing its digital health policies allow for “innovators to create COVID-19 related public health solutions” such as mobile apps used by the CDC and state and local health departments to manage their response to the crisis.
The regulatory agency made a blanket statement that it “does not consider most apps and software systems for public health surveillance and communication to be medical devices regulated by the FDA.” But the scope of the regulation remains murky in terms of what it intends to regulate during the national emergency.
Bradley Merrill Thompson, a medical device regulatory attorney at Washington, D.C.-based Epstein Becker Green, said while he appreciates the FDA’s attempt to spur innovation in response to the pandemic, the statement from the agency is ”useless” public relations. “It just doesn’t say what is and what is not permitted in a very clear way,” according to Thompson. …
However, Thompson called Thursday’s communication from FDA a “marketing” piece that is “just a simple repeat of what’s already out there” couched within the context of the current coronavirus crisis.
“They should put out a structured guidance which can be interpreted by people trying to bring out products that would be useful in the battle against this virus,” Thompson said. Without more concrete guidance, he complained developers can only guess about what is and what is not permitted.
Looking at the September 2019 guidance, Thompson surmised that a machine learning algorithm relevant to the COVID-19 outbreak could be an example of what FDA does in fact plan to regulate.
That kind of clinical decision support software could categorize likely symptoms based on location and electronic health records to help healthcare providers, he argued, and as a result would probably require regulatory oversight of this kind of software. “Now this example may be impacted by the emergency guidance released a couple of weeks ago,” Thompson added. “It’s not completely clear.”