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 Bloomberg BNA Medical Devices Law & Industry Report, in “Fiscal 2016 Device Guidance List,” by Michael Williamson.
Following is an excerpt:
Bradley Merrill Thompson, a device and combination product attorney at Epstein Becker & Green PC in Washington, told Bloomberg BNA in a Dec. 28 e-mail that he is disappointed the FDA didn’t publish its promised guidance on medical device decision support software in FY 2015, even though it was an A-list item that year … .
According to Thompson, the FDA originally announced its intention to publish the device decision support software draft guidance in 2011. “A lot of companies are struggling to understand the rules and in particular the scope of FDA regulation of CDS [clinical decision support] in the absence” of the device decision support draft guidance, he said, adding, “I fear it is greatly hindering innovation in that space. In fact, we are doing an industry survey to find out what the impact of the continued ambiguity is on the CDS industry.”
However, Thompson said he is “quite glad” to see the FDA announce its intention for a draft guidance on software modifications. He said he gets a “tremendous” number of questions from software developers who want to know how modifications will be treated, and there’s very little current guidance to draw upon.