Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg BNA Medical Devices Law & Industry Report, in “Medical Software Group Presses FDA for Regulatory Clarity,” by Michael D. Williamson.
Following is an excerpt:
The petition is in response to a February meeting the coalition had with the FDA's Office of Combination Products, Thompson said.
At that meeting, the coalition discussed three hypothetical software products and if they would be regulated as a medical device by the FDA, Thompson told Bloomberg BNA.
The meeting yielded “a very productive discussion in which the agency asked many good questions to better understand the scenarios and our specific” concerns, he said.
However, the FDA later concluded it couldn't “share its thinking” on the hypothetical products discussed at the meeting without violating the agency's good guidance practices, Thompson told Bloomberg BNA.
The FDA said “that answering questions in an area where the agency lacks guidance would, in effect, be providing guidance without going through required notice and comment,” according to Thompson.
