Government Shutdown Causes Backlog Of 100 Device Submissions, With More Expected

CDRH says it received 101 device submissions during the two-week government shutdown, and has logged them into its system. The center also expects an increased number of submissions in the coming weeks, but remains confident it will meet its MDUFA review timelines.

The device center announced Oct. 24 that it received 101 device submissions during the 16-day government shutdown, and expects even more in the coming weeks from companies that may have avoided submitting due to the shutdown.

During the shutdown, FDA was not allowed to formally accept or log in any user-fee funded device submissions, including PMAs...

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

Investors Urged To Prioritize Patient Engagement To Ensure Clients’ Products Succeed

 

To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.

EU Life Sciences Strategy Must Address ‘Regulatory Lasagna’

 

MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”

FDA Publishes Final Cybersecurity Guidance To Replace Final Cybersecurity Guidance

 

The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.

New Regulation Significantly Expands eIFU Usage Scope

 

Amendment brings new benefits for device accessories and aesthetic devices used by healthcare professionals.

More from Policy & Regulation

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
• By 

Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.

June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 

The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.