Bradley Merrill Thompson Quoted in “FDA Officially Halts Oversight of Passive Device Data Systems”

Pharma & MedTech Business Intelligence's The Gray Sheet

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 “FDA Officially Halts Oversight of Passive Device Data Systems,” by Ferdous Al-Faruque. (Read the full version — subscription required.)

Following is an excerpt:

“FDA is certainly sticking to its word, working to down classify or altogether exempt low-risk software-based technologies,” said Bradley Thompson, general counsel for the Clinical Device Software (CDS) Coalition. “The implications [of the MDDS guidance] are profound, both for MDDS type software, but also for what it suggests about the future for health information technology generally. FDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software.”