Bradley Merrill Thompson Quoted in “CDRH’s Guidance Goals for 2017”Medical Device and Diagnostic Industry (MD+DI) December 29, 2016
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 Medical Device and Diagnostic Industry (MD+DI), in “CDRH’s Guidance Goals for 2017,” by Marie Thibault.
Following is an excerpt:
Brad Thompson, JD, MBA, general counsel of the Clinical Decision Support (CDS) Coalition and a member of MD+DI’s editorial advisory board, told MD+DI that in order to be regulated by FDA under The 21st Century Cures Act, CDS software cannot be “transparent.” He explained in an email that “transparent” software would allow a physician to “see through the software to the underlying patient data and the clinical logic applied by the software, such that the physician is not required to rely on the software.”
CDS Coalition hopes FDA will still address the guidance topic. Thompson outlined three key issues the group is looking for in such guidance:
- FDA’s risk stratification and delineation of regulated versus unregulated CDS software
- FDA’s plans to apply the concept of “transparent” software
- FDA guidance on CDS software related to pharmaceuticals
“The guidance is more important now than ever before,” Thompson wrote.