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 the Bloomberg BNA Medical Devices Law & Industry Report, in “Medical Software Industry Issues Guidance to Keep FDA at Bay,” by Bronwyn Mixter. (Read the full version – subscription required.)
Following is an excerpt:
Bradley Merrill Thompson, counsel for the CDS Coalition, told Bloomberg BNA Aug. 30 the guidelines provide best practices that software developers should think about when they’re creating medium-risk products. He said they explain how a developer can get the user mentally engaged in the thought process and how the software should be labeled to ensure that only the right people use it.
Thompson said the software shouldn’t be used to empower health-care professionals to do more than they’re capable of doing. For instance, he said an unlicensed nurse shouldn’t use the software to make a diagnosis.
“There needs to be a matching of qualification of the user to the decision-making process,” Thompson said.
Thompson is also a device and combination product attorney at Epstein Becker & Green PC in Washington and a Bloomberg BNA advisory board member.
