1. Medtech Insight
  3. >>Regulation

Group Urges Advisory Opinions For Clinical-Decision Support Products

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 for the industry

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

More from Policy & Regulation

New Treatment For Chronic Facial Pain Could Launch By Fall 2025

 
• By Elizabeth Orr

NeuroOne is preparing to submit its OneRF Trigeminal Nerve Ablation System to the US FDA for treating trigeminal neuralgia, a chronic facial pain condition. CEO Dave Rosa told Medtech Insight that he expects a possible product launch by fall 2025.

Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
• By Brian Bossetta

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

Global Medtech Guidance Tracker: April 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 25 documents have been posted on the tracker since its last update.