FDA Proposes Plan To Speed Medical Device Reviews
The approach, which would focus on first-of-a-kind devices with the potential to make a significant difference for patients, could cut in half the current amount of time spent reviewing most new devices.
The Associated Press: FDA Aims To Accelerate Medical Device Reviews
Federal health officials are proposing a plan that would speed up the approval of innovative medical devices that have the potential to dramatically improve patients' lives. The so-called Innovation Pathway, announced Tuesday by the Food and Drug Administration, would aim to review first-of-a-kind devices in five months, which is half the time currently spent reviewing most new devices. The FDA has had an accelerated approval program for drugs since 1992, but never one for devices. The initiative comes amid complaints from medical device manufacturers that U.S. review times lag behind other countries (2/8).
Reuters: Novel Health Devices Could See Faster Reviews
Health regulators are seeking to speed up their reviews of promising medical devices and boost research for new technologies in hopes of getting novel products to market faster. The initiative targets "devices that are true pioneering technologies and that have the potential to revolutionize patient care or health care delivery," the Food and Drug Administration said on Tuesday (Heavey, 2/8).