Group Urges Advisory Opinions For Clinical-Decision Support Products

 
• By Ferdous Al-Faruque
  
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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.

In August, the coalition sent FDA a citizen petition asking it to consider using an advisory-opinion model to develop guidances...

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