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 “FDA Seeks Input on Clinical Evaluation of Software as a Medical Device,” by Greg Slabodkin.
Following is an excerpt:
While this is a document developed by the IMDRF, when finalized the guidance will represent FDA’s current thinking on the topic of the clinical evaluation of standalone software. As such, Bradley Merrill Thompson, an attorney at Washington-based law firm of Epstein Becker Green who counsels medical device companies on regulatory issues, believes this guidance is a big deal.
“Digital health is an exploding field, so this may affect quite a few products down the road,” says Thompson. “There are a huge number of mobile apps as well as stand-alone programs for PCs that are finding their way into the practice of medicine, and this guidance lays out the requirements for clinical evaluation.”
Typically, clinical evaluation is one of the most expensive aspects of product development, “so the requirements of this guidance have a major impact on both the cost and the time frames for bringing products in these categories to market,” he says.