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

Draft Guidance Tackles Common Errors In Adverse Event Reporting

A revised guidance on medical device reporting fleshes out FDA’s thinking on manufacturers’ responsibilities in various situations.

FDA issued a revised guidance on its medical device reporting requirements for manufacturers, including a new “frequently asked questions” section and a list of common errors made by device companies in their adverse event reports to FDA.

The draft guidance, which will replace FDA’s 1988 and 1997 MDR guidances once finalized, explains FDA’s regulations for manufacturer adverse...

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

More from Policy & Regulation

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.

EU Life Sciences Strategy Must Address ‘Regulatory Lasagna’

 
• By Amanda Maxwell

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.”

Questions Over UK Prevention Agenda Within NHS 10-Year Plan

 
• By Ashley Yeo

The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.