510(k) reform: FDA’s medical device unit review due out Friday
The Institute of Medicine will release the highly anticipated results of its year-long investigation into the FDA’s medical device review process at the end of this week.
The IOM was tasked by the FDA to do a soup-to-nuts review of the program in late 2009 and many in the industry are fearful that the institute will call for sweeping changes and that the FDA will follow suit.
The FDA said earlier this month that it was “not bound” by the IOM’s recommendations, and that it “will consider them and make its own decisions,” according to minutes of a June 17 meeting between medical device industry and agency officials.
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