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 eHealth Law & Policy Journal, in “Coalition Survey Highlights CDS Uncertainty.”
Following is an excerpt:
“Compliance with FDA requirements are a major driver in the cost of developing software. Not knowing such an important factor has scared off many investors,” explains Bradley Merrill Thompson, Member at Epstein Becker & Green, “Why wouldn’t developers simply ask the FDA? Firstly, there is very little consensus within the agency regarding its approach. Second, having to ask for each and every iteration of the software is perilous for developers, because the software constantly changes.”
FDA guidance is yet to be issued but has been promised since 2011. “Given the complexity of the issues, there will almost certainly be a need for FDA guidance, whether Congress legislates on CDS or not,” adds Thompson.
