Abiomed Letter Underscores Questions On FDA’s Clinical Decision Support Guidance

A warning letter from the US FDA to device manufacturer Abiomed highlights industry’s criticism that the agency’s final guidance on clinical decision support software is flawed and oversteps regulatory boundaries.

Regulations
• Source: Shutterstock

When the Food and Drug Administration issued its final guidance last year on clinical decision support (CDS) software, some criticized the agency for taking a much broader approach than it had laid out in its draft guidance a few years prior.

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

More from Regulation

More from Policy & Regulation