1. Medtech Insight

Lab-Developed Test Regs In Spotlight With Citizen Petition, Hamburg Speech

The American Clinical Laboratory Association filed a citizen petition with FDA June 4 reiterating and formalizing its long-held opposition to FDA regulating laboratory-developed test services. The petition closely followed a speech from FDA Commissioner Hamburg emphasizing plans to do just that.

A controversial area of FDA diagnostics regulation gained renewed attention this week with a citizen petition sent to FDA from clinical laboratories and a speech from FDA Commissioner Margaret Hamburg.

The American Clinical Laboratory Association filed its citizen petition with FDA June 4 reiterating and formalizing its long-held...

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