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 Health Data Management, in “FDA Seeks Feedback on Plan for Medical Device Interoperability,” by Greg Slabodkin.
Following is an excerpt:
However, the FDA does not have the legal authority to “define for the whole ecosystem how the ecosystem should operate, or according to what standards product should be made,” contends Bradley Merrill Thompson, an attorney at Washington, DC-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues
According to Thompson, the agency, by its very charter, is a passive regulator. “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,” he asserts. “Manufacturers have complete control over their intended use, and if they want to make their products useful only with specific other products, that’s their right.”