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 POLITICO Morning eHealth, in “Dispatch from FDA/CTA Digital Health Tech Expo,” by David Pittman and Darius Tahir.
Following is an excerpt:
Jeff Shuren, the head of FDA’s device center, mused about a new structure for software regulation: a pre-clearance of sorts for software modifications. A company with a solid record in a certain area might receive a pre-clearance, allowing it to push software notifications automatically without the need for regulatory approval. The company would still need to gather data about the effectiveness of the changes, just to make sure there weren’t any dangerous tweaks unleashed into the world. ...
FDA regulatory attorney Bradley Merrill Thompson: “I gather his idea is something along the lines of a company achieving a certification of competence to do certain validation testing or other quality assurance tasks, as a way to reduce the number of submissions for modifications. That’s actually a very clever thought.”
