CDRH Prepares For Electronic Recall Submissions; Pre-Market Still A Challenge

Device recall reports may be submitted via FDA’s eSubmitter platform beginning in the coming months. Meanwhile, full-fledged electronic submissions of pre-market device applications are still a ways off.

FDA will begin to accept electronic submissions of device recall actions in the next several months, but it will still be some time until most pre-market device submissions can be made online, according to a staffer at the device center.

Currently, device makers submit correction and removal reports for products to an FDA district office in paper format. The reports...

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

Commission Decision Launches Pediatric And Rare Disease Expert Group

 

A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.

Dermal Fillers For Décolletage May Gain FDA Approval

 
• By 

An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.

Planning To Take Part in MDUFA? FDA Wants To Hear From You

 

The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it. 

More from Policy & Regulation

Planning To Take Part in MDUFA? FDA Wants To Hear From You

 

The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.

Global Medtech Guidance Tracker: June 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.