1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

Bumps In The Road As US FDA Tries To Catch Up From Shutdown

 
• By David Filmore

The recently ended record-setting US government shutdown is not anticipated to have a long-term impact on US FDA device review times. But agency reviewers will face more 510(k) review deadline pressures than usual and may have limited availability for pre-submission meetings in the short term, one expert suggests.

Road Marking - Image

Staffers at US FDA's document control centers are busy this week as the agency hastens to log in the pre-market submissions that were blocked from entry during the recently ended five-week partial government shutdown.

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 Regulation

Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
• By Brian Bossetta

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By Elizabeth Orr

A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
• By Amanda Maxwell

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

More from Policy & Regulation

South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By Elizabeth Orr

A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
• By Amanda Maxwell

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.