1. Medtech Insight
  2. >>Digital Technologies

US Senators Question FDA's Pre-Cert Program Authority, Concerned About Safety

Top Democratic lawmakers on the Senate HELP Committee have written to US FDA Commissioner Scott Gottlieb with questions about the agency's ongoing work to develop a pre-certification program that would allow medical software-makers to gain the agency's trust as a means to benefit from reduced or no pre-market review.

Capitol House

Three top Democratic Senators on the US Senate Health, Energy, Labor and Pensions Committee (HELP) want answers on US FDA's planned pre-certification program; they've sent Commissioner Gottlieb an extensive list of questions on the subject. The lawmakers are concerned the agency may be moving forward without proper statutory authority and are concerned the program may not provide the oversight needed to ensure medical software products meet the agency's level of safety and efficacy.

The agency has been developing the program, which remains in a pilot phase, for about the past two years. The...

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 Digital Technologies

Ready For Lift-Off: India’s Medtech Industry Sees Rapid Advancement

 
• By Ashley Yeo

C-suite executives from Stryker, Intuitive Surgical and Fresenius passed a mainly upbeat verdict on the Indian medtech market and industry.

Medicare’s TCET Pathway Wins Acclaim From Early Users, Even As ‘Messy Middle’ Persists

 
• By Brian Bossetta

Some of the first manufacturers to receive Medicare coverage for their breakthrough devices through the Transitional Coverage for Emerging Technologies pathway praise CMS’ engagement and timelines in the process, despite some challenges around post-launch data collection.

Spanish Draft Bill Would Improve Clinical Research Use of Health Data

 
• By Francesca Bruce

Spain is drafting a new digital health bill that aims to ensure the country is ready to implement the European Health Data Space Regulation.

New Funding Models For Medtech Emerge As Traditional Venture Capital Pulls Back

 
• By Marion Webb

Family offices, impact funds, and public-private partnerships are among alternative approaches to financing that stress early-stage investment, collaboration, impact and health equity – but not, at least for family practices, AI.

More from Medtech Insight

Veris Health Expands Oncology Monitoring Platform, Plans Implantable Sensor By 2026

 
• By Marion Webb

Banking on new billing codes for remote services, PAVmed’s Veris Health is expanding its oncology remote monitoring platform with Ohio State’s cancer center and developing an implantable physiological monitor to provide clinicians with continuous insights between treatment visits.

Ready For Lift-Off: India’s Medtech Industry Sees Rapid Advancement

 
• By Ashley Yeo

C-suite executives from Stryker, Intuitive Surgical and Fresenius passed a mainly upbeat verdict on the Indian medtech market and industry.

Medicare’s TCET Pathway Wins Acclaim From Early Users, Even As ‘Messy Middle’ Persists

 
• By Brian Bossetta

Some of the first manufacturers to receive Medicare coverage for their breakthrough devices through the Transitional Coverage for Emerging Technologies pathway praise CMS’ engagement and timelines in the process, despite some challenges around post-launch data collection.