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Compliance In Focus
Posted by John Lehmann on Mon, Dec 5, 2011

FDA Forming an Expert Panel

Back in October, Reuters reported that the FDA is seeking public input on a plan to create a network of outside experts to help understand the new technology in medical devices. The goal of panel would be to help speed up device approvals.

The program is part of the agency's efforts to reform the 510(k) approval process. There has been much controversy surrounding the 510(k) process. The Institute of Medicine (IOM) recently reported that the process did not adequately protect patients and calls for an overhaul of the process.

Currently, the FDA's devices center already has a staff of scientist, engineers and clinicians, but they often reach out for external expertise in reviewing products. The experts in the pilot program will not provide policy advice, but will be asked to help the staff form their own conclusions.

Do you feel this panel approach will add any value to the 510(k) review process? If not, please explain why.

Topics: john lehmann, FDA, 510(k)


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