Bradley Merrill Thompson, a 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 “FDA Proposes Ban on Certain Electrical Stimulation Devices,” by Michael Williamson.
Following is an excerpt:
The fact is, banning a device is a very labor-intensive process for FDA to pursue, with many procedural steps along the way, Thompson said. “That’s why, among other things, they seem to reserve it for only the most significant cases,” he said.
When asked to explain why he isn’t concerned about the FDA proposing more device bans, Thompson said that, in this particular instance, the agency is taking on a product that frankly isn’t very popular and is only used one place.
Further, the FDA typically steers clear of anything that could be considered the practice of medicine, focusing only on products that are inherently risky, Thompson told Bloomberg BNA. “I think they must have a very deep concern about the safety of these electrical stimulation devices, and legally they must have concluded that banning them is the most appropriate legal remedy.”