Commissioner Defends FDA On Duodenoscope, LDT Actions At Senate Hearing

In her last appearance before a Senate committee March 10, FDA Commissioner Margaret Hamburg presented a strong defense of FDA’s actions to address contaminated duodenoscopes, regulation of lab developed tests and other hot button issues raised by Senators, who also praised her leadership at FDA.

Outgoing FDA Commissioner Margaret Hamburg was challenged March 10 by members of the Senate Health, Education, Labor, and Pensions Committee on duodenoscopes involved in recent bacterial outbreaks and laboratory developed test regulations, among other hot button issues.

Hamburg, along with National Institutes of Health Director Francis Collins, was called before HELP to launch a series of hearings...

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

23andMe Genetic Tests Among 12 New FDA Classifications

 
• By 

A late-August batch of device classifications from the US FDA includes genetic tests from 23andMe, hand-held spinal surgery tools, and several IVDs.

Why EU Innovators Face Growing Barriers With EU Combination Product Regulation

 

Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.

UK MHRA Ready To Evolve Approach To In-House Manufactured Medtech

 
• By 

The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.

FDA Panel Supports Dermal Fillers For Décolletage Use

 
• By 

An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.

More from Policy & Regulation

Why EU Innovators Face Growing Barriers With EU Combination Product Regulation

 

Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.

NeuroOne Prepares To Launch Trigeminal Nerve Ablation System

 
• By 

The US FDA has cleared NeuroOne's OneRF trigeminal nerve ablation system for the treatment of trigeminal neuralgia. This minimally invasive method utilizes radio frequency energy to alleviate pain, offering an alternative to traditional medications and surgeries. A fall commercial launch is planned.

Warning Letters - July 2025

The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.