Bradley Merrill Thompson, a Member of the Firm in the Healthcare and Life Sciences practice, in the Washington, DC office, was quoted in an article titled “Analyst Says FDA’s Work Need Not Stifle Innovation in Mobile Health Care Apps.”
Following is an excerpt:
New guidelines published by the Food and Drug Administration for the oversight of mobile health care applications will not stifle innovation in the industry, a leading health care analyst said July 29.
Bradley Merrill Thompson, agreed that the guidance represents “a clarification in the law; not a change in the law.” Thompson said the guidance gives a better understanding of FDA interpretation. The areas subject to regulation—applications meeting the definition of a device, accessories to those devices, and accessories used to transform a mobile platform into a regulated device—”might seem like a small universe,” Thompson said, but they lead to many levels of interpretation.
An example, he said, is software that only provides decision support. It may be just a cell phone with an app, but if it provides decision support analysis—even if manually entered—it could be regulated. Thompson advised conference attendees to study Footnote 13 of the draft guidance for a better understanding of where FDA may go for future regulation.
Four different categories of manufacturers could be regulated, Thompson continued: mobile medical app manufacturers, including specification developers; mobile platform developers; distributors; and component supplier manufacturers. Key questions, he said, are what gets regulated and to what level, or device classification. Intended use determines whether a company is regulated, Thompson said, and that depends on the types of communications or claims that are made for a product. He said the coalition will urge FDA not to “overreact” and impose regulation on apps that are intended to promote general wellness.
Software is a “difficult issue” because FDA is 20 years or 30 years behind in its regulation, Thompson said. The coalition will propose comprehensive mapping and a policy on modularization that provides separation to avoid “pollution” of a low-risk app by a high-risk one. He said FDA should come up with an approach for classifications that categorizes software more by function than features, allowing them to “evolve over time.”