1. Medtech Insight
  2. >>Device Area
  3. >>Diagnostics
  4. >>In Vitro Diagnostics

'Reined-In' US Diagnostics Legislation Adds Pre-Certification, Other Updates

 
• By Sue Darcey

A revised bill is circulating in both the US House and Senate to revamp FDA regulation of diagnostics. It would allow the agency to leverage a pre-certification process to validate test developers and includes other updates that are likely to appeal to the lab sector. But user fees and other elements could still be contentious.

Medic staff at work in the laboratory. Background

Clinical laboratories and IVD-kit manufacturers could be pre-certified by US FDA to help bypass review and approval of their diagnostics under a draft bill floating in Congress, the "Verifying Accurate Leading-edge IVCT Development" (VALID) Act.

Provisions addressing pre-certification, along with a section allowing third-party review of certain test categories, are among several updates to 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 In Vitro Diagnostics

Waters’ Purchase Of BD Biosciences & Dx Brings Growth Potential Alongside Trade-Offs

 
• By Marion Webb

Waters Corp. will acquire Becton Dickinson’s Biosciences and Diagnostics business for $17.5bn, doubling its TAM to $40B. Analysts praise the flow cytometry addition but see weaker growth in diagnostics.

Thena Capital’s New Fund Up And Running With £1M Investment In Plexāā’s Breast Cancer Device

 
• By Natasha Barrow

Thena Capital, the first UK-based early-stage specialist medtech firm, has made its first investment since closing its £50m fund. Medtech Insight spoke with general partner Pamela Walker Geddes to gain insight into Thena Capital’s investment strategy.

Milner Pitch Day: Multiomic Pathology, Microcancer Avatars And Cell Morphology Intelligence

 
• By Natasha Barrow

The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.

Dxcover Launches US Operations With New Headquarters In Tennessee

 
• By Natasha Barrow

Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.

More from Diagnostics

Milner Pitch Day: Multiomic Pathology, Microcancer Avatars And Cell Morphology Intelligence

 
• By Natasha Barrow

The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
• By Elizabeth Orr

Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.