Bradley Merrill Thompson Quoted in “FDA Device Interoperability Guide Offers Clarity, But Lacks Incentives”FDA Week January 28, 2016
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 FDA Week, in “FDA Device Interoperability Guide Offers Clarity, But Lacks Incentives,” by Joe Williams.
Following is an excerpt:
Brad Thompson, a medical device attorney with Epstein Becker & Green, said 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.
"All FDA has the legal authority to do is to 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," he said.
Thompson added he thinks the guidance is a good first draft and includes important advice for manufacturers, but a more comprehensive scheme for interoperability would have to come from elsewhere.