Bradley Merrill Thompson Discusses FDA’s Draft Guidance on Medical Device Interoperability with Multiple Publications

Meanwhile, Bradley Merrill Thompson, an attorney with Epstein Becker & Green, P.C., tells FierceHealthIT that the recommendations play a “limited role,” but also calls the guidance “important advice” for device manufacturers. He points out that the FDA does not have legal authority to define operations for the whole healthcare ecosystem.

“All FDA has the legal authority to do is convey through guidance, what the agency expects in the way of appropriate labeling, design, validation and so forth for products that the manufacturer intends to be interoperable with some other devices, either specified or not,” Thompson says. “FDA can and does play an important role in defining the minimum required labeling, design, validation and so forth to support a product intended to be interoperable. They just can’t force a product to be interoperable, nor can they tell the manufacturer with which other products they, the agency, want the product to be interoperable.”