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 Pharma & MedTech Business Intelligence’s The Gray Sheet, in “Updated SOFTWARE Act: Still Too Ambiguous for Industry?” by Ferdous Al-Faruque. (Read the full version — subscription required.)
Following is an excerpt:
Bradley Thompson, a counsel at the law firm Epstein, Becker and Green who has been active in advocating regulatory positions for mHealth firms, says while he’s happier with the new language he still has some concerns. He says he likes the language used to codify clinical-decision support software transparency as one criteria for regulation, but he doesn’t think it goes far enough.
“So while FDA should consider the transparency of the software, the legislation certainly does not say that transparent software should always be unregulated,” said Thompson. “It is still simply one factor that FDA should take into account. Honestly, that’s the status quo.”
He argues the proposed bill does not create a “roadmap” for sponsors to understand whether their software will be regulated or not but instead gives guidance to FDA on how to make that decision.
“We need legislation that is self-executing, that provides the software development community with clear delineation as to what’s in and what’s out,” added Thompson.