House Chair Wants Answers On The FDA’s Handling Of Dangerous Device

The Chairman of the US House Subcommittee on Economic and Consumer Policy is pressing the FDA on why it allowed what he says is a dangerous medical device to stay on the market for so long.

Time For Answers
• Source: Alamy

Rep. Raja Krishnamoorthi, D-IL, who chairs the House Subcommittee on Economic and Consumer Policy, wants to know the Food and Drug Administration’s thinking on how it handled a medical device that was widely believed to be dangerous.

In a 22 March letter to FDA Commissioner Robert Califf, Krishnamoorthi expresses concern over why the HeartWare Ventricular Assist Device (HVAD) System was allowed to remain on the market...

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

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By 

Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.

Zika Virus Test Among 4 New FDA Device Classifications

 
• By 

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

More from Policy & Regulation