Bradley Merrill Thompson Quoted in “Group Urges Advisory Opinions for Clinical-Decision Support Products”MedTech Insights September 16, 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 MedTech Insights, in “Group Urges Advisory Opinions for Clinical-Decision Support Products,” by Ferdous Al-Faruque.
Following is an excerpt:
The Clinical Decision Support Coalition is urging US FDA to use an advisory-opinion model guidance format to help clarify its thinking on clinical-decision support products that does not lock the agency into an approach that can't keep up with a rapidly changing sector.
The Clinical Decision Support (CDS) Coalition says US FDA has accepted its request to meet and discuss a citizen petition filed by the group recently urging the agency to develop much-needed guidance for the sector. However, the agency has not set a date for the meeting yet, according to Bradley Thompson, an attorney with the law firm Epstein Beck Green who represents the CDS Coalition.