Group Urges Advisory Opinions For Clinical-Decision Support Products

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.

In August, the coalition sent FDA a citizen petition asking it to consider using an advisory-opinion model to develop guidances for the industry. The group says it tried to think...