FDA forms expert panel to speed up device approval

The health regulator said it is seeking public input on a plan to create a network of outside experts who would help understand new technology in medical devices, potentially speeding up device approval.

The Food and Drug Administration said on Tuesday it had formed a pilot committee of such experts, which will run through December 30 and expand the pool of vetted sources the agency already has.

Although the agency’s devices center already has a staff of scientists, engineers and clinicians, the FDA often draws on external expertise in reviewing products, especially in areas where knowledge can change rapidly.

The experts in the pilot program will not provide policy advice or opinion but will help center staff form their own conclusions.

The program is part of the FDA’s efforts to reform its fast-track approval process for medical devices, called 510(k). In recent years the agency’s devices unit has been dogged by high staff turnover, funding woes and major recalls.

Earlier this year, the Institute of Medicine, in a report to the FDA, said 510(k) did not adequately protect patients and recommended a more thorough process that would likely raise the costs for device makers.

For their part, device makers say agency reviewers lack adequate training and are too slow at approving devices.

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(Reuters)