House Diagnostics Reg Reform Draft Proposes Pathways For Relaxed Scrutiny

A House Subcommittee plans to take up draft legislation at a hearing next month that brings together test kits and lab-developed tests into a new regulatory category. The proposal offers many ways for tests to avoid a “high-risk” classification. “The Gray Sheet” compares the provisions to recent proposals vetted in the Senate.

The House Energy and Commerce Health Subcommittee will consider a legislative discussion draft

to establish new regulated medical product category of in vitro clinical tests to counter FDA’s proposed laboratory

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 Legislation

More from Policy & Regulation