Institute Of Medicine Clarifies It Is Not Seeking Tougher Bar For Class II Devices
A week after issuing a scathing assessment of FDA’s 510(k) pre-market clearance program, the Institute of Medicine clarified that it is not recommending a tougher pre-market bar for all class II devices.
Cognizant of the uproar caused by the July 29 report, which urged FDA to replace the 510(k) program with a new process that better ensures the safety and effectiveness of devices, the IOM committee appears to be downplaying some of its major concerns about the program. (See “ Institute Of Medicine On 510(k) Review Program: Dump It ” – “The Gray Sheet” Aug. 1, 2011.)
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
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