FDA Unlikely To Face Suit Over Consideration Of IOM 510(k) Report
A free speech group questioning the legality of the composition of a controversial Institute of Medicine panel that drafted a report on the 510(k) medical device clearance process said it is unlikely FDA will face legal action for considering the panel’s proposals. The agency dismissed the committee’s controversial call to replace the 510(k) clearance process, but is still weighing the panel’s other recommendations and is facing pressure from various stakeholders to revisit the 510(k) replacement idea.
Shortly after the IOM report was released amid industry criticism, FDA said the current system should not be eliminated, but that it would consider other changes. The agency is collecting comments on the committee’s recommendations and will have a public meeting next month.
New Data Shows Decline in Medical Imaging Utilization
A new analysis of Medicare data finds that spending on medical imaging continues to decline and that Medicare patients are receiving fewer imaging procedures. Learn More
MITA Now Includes Radiopharmaceutical Industry in Membership
With new membership MITA unites both halves of nuclear medicine. Learn More
CT Lung Cancer Screening Named Top Five Advance in 2011
The American Society of Clinical Oncology (ASCO) named CT-based lung cancer screening amongst 2011’s top five advances in its annual report on progress against cancer. Learn More
- © 2012 National Electrical Manufacturers Association |
- Privacy Policy |
- Terms & Conditions