Bradley Merrill Thompson Quoted in “International Forum Issues Guidance Framework on Regulating Device Software”

Bloomberg BNA's Medical Devices Law & Industry Report


Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "International Forum Issues Guidance Framework on Regulating Device Software."

Following is an excerpt:

An international regulators' group April 2 issued a draft guidance that would establish a common framework for the international community to use to regulate software as a medical device (SaMD). ?...

Attorney Bradley Merrill Thompson, with Epstein Becker & Green PC in Washington, told Bloomberg BNA April 2 the draft guidance itself is a "mixed bag" of policies, but the fact that it was even published is significant.

Essentially, he said the guidance is "just the collective musings of the international regulatory community," but it's coming at a time when individual countries are developing their own policies regarding software regulation. So even though it's not a law, Thompson said he expects the framework will be influential.

"The international community is out ahead of the regulators," Thompson said. "They're talking before the individual countries have developed procedures."

Thompson is a founder of the mHealth Regulatory Coalition and the Clinical Decision Support Coalition, groups that have sent recommendations to the FDA and Congress about regulating mobile health and health software.

Thompson said a lot of the broad concepts in the framework are not usually found in the U.S. regulatory tradition. For example, he said the draft focuses heavily "on the relationship between the role of the software and the disease" and gets into the nuances of the intended use of the software.

Thompson said it's difficult to tell how the IMDRF draft guidance specifically relates to FDA regulation, since the agency has thus far only issued a guidance on regulating mobile medical applications. Guidances on other aspects of software regulation, like clinical decision-support software, are still under development, he said. The FDA subsequently issued a proposed strategy for regulating health information technology.