1. Medtech Insight
  2. >>Geography
  3. >>North America
  4. >>United States

Adverse Events Stack Up At FDA; 2016 Warning Letter Data Show Troubles With MDRs, Complaints

 
• By Shawn M. Schmitt

The US agency is inundated with adverse events through its Medical Device Reporting system with more than 1.4 million sent to FDA in 2015. Yet several industry experts – including from Eli Lilly and Implant Direct (Danaher) – say the industry overall may be underreporting adverse events, while some firms are overreporting. Preliminary 2016 warning letter data compiled by Medtech Insight also pinpoint problems with MDRs and complaint handling. Meanwhile, quality officials debate what makes a good complaint handling system, and tell what FDA expects from manufacturers. Plus: check out Medtech Insight's new FDA Warning Letters Data Tracker.

Serious businessman with red umbrella under huge wave of documents

Problems with a bevy of specific devices, better adverse event reporting by manufacturers, and enhanced industry and public awareness about what's reportable to FDA when a product fails are three possible reasons why the number of Medical Device Reports (MDRs) swelled to an all-time high of more than 1.4 million last year, the US agency says.

Yet several industry experts – including from Eli Lilly and Implant Direct (Danaher) – say not only is there underreporting going on, but adverse events are overreported in many cases,...

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 United States

ConcertAI Launches Generative AI-Powered Precision Suite

 
• By Natasha Barrow

Valued at over $1.9bn, ConcertAI is building on its pre-existing multi-agentic AI SaaS solution CARAai to bring life science customers the new Precision suite of applications: Precision Explorer, Precision Trials, Precision GTM and Precision360.

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
• By Brian Bossetta

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

More from North America

Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Bone Surgery Startup Surgify Medical Raises $7.9m

 
• By Natasha Barrow

Surgify Medical’s selective drill tip, Surgify Halo, is “an obvious choice for surgeons,” said Boris Hofmann, head of ZEISS Ventures and lead investor in the company’s series A funding round.

German Bionic Launches ‘Strongest Exoskeleton To Date’

 
• By Natasha Barrow

German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.