Program for Approval of Medical Devices to be Discussed by FDA
Medical Devices

A new program which aims at speeding up US approval of some medical equipment is all set to face closer scrutiny and discussion on Thursday, at a meeting of the Food and Drug Administration which is expected to analyze potential changes to the controversial program.

Critics have asserted that speeding the process for reviewing medical devices and making it more like other products which are currently available across the US market, have been expanded beyond the initial goal, and this has led to problems with devices after they have been purchased.

The meeting to discuss the new process, known as 510(k), is the latest in a range of changes for the FDA's devices division, which has seen a significant transformation under the Obama Administration and managed to create much uncertainty for manufacturers of medical devices.

Nearly 3,500 devices are cleared each year under the 510(k) system. Meanwhile, about 50 devices are approved each year under the more stringent system.

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