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 Health Data Management, in “Senate Bill Imposes Limits on FDA Regulation of Apps, Software,” by Greg Slabodkin.
Following is an excerpt:
Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who supports the MEDTECH Act, argues that the uncertainty with regard to the scope of FDA regulation has meant that many developers have needed to shelve promising projects because they couldn’t tell investors whether the products required regulatory clearance or not.
“Compliance with FDA requirements, both premarket as well as quality system requirements, is a major driver in the cost of developing software,” contends Thompson, who serves as general counsel for the Clinical Decision Support (CDS) Coalition—which includes software developers, patient advocacy organizations, clinical societies, providers, and payers. “Not knowing such an important factor has scared off many investors.”