Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Dive, in “FDA Finalizes Guidance on How Clinical Decision Support Software Is Regulated,” by Nick Paul Taylor.
Following is an excerpt:
The FDA received 108 comments on the 2019 draft. Key stakeholders voiced support for the draft, which the Advanced Medical Technology Association, a trade group, called “an important step in clarifying the types of software that are, or are not, subject to FDA’s regulatory oversight.” The trade group also raised concerns and called for changes.
Bradley Merrill Thompson, an attorney who works with medical device firms on regulatory issues, said in an emailed statement that the guidance is “hugely different” from what the FDA proposed in 2019, pointing to a section where the agency is trying to draw a distinction between how “self-confident” software is when making recommendations to doctors. For example, distinguishing between software that will say directly what a diagnosis is and software that will be more tentative and say a diagnosis is probable.
“I’m appalled that FDA would make such radical changes from a proposal and go right to final, without publicly vetting the language first in a re-proposal,” Thompson, an attorney with the law firm of Epstein Becker Green in Washington, wrote in the statement. “It is almost certain to cause confusion and indeed conflict because FDA’s new interpretations are far from what Congress provided in its statutory language.”