Public Citizen's health research group for years has asserted that the FDA's procedures for clearing medical devices under the 510(k) process are flawed and fail to adequately protect public health."
Challoner rebuffed suggestions that existing regulations already thwart medical device innovation and that the IOM recommendations will only make the situation more difficult. "There is no way of assessing, based on a review of available evidence, whether current regulations are having either a positive or a negative effect on innovation. He suggested that the FDA commission to review the issue.
For its part, the FDA said it already has underway efforts to incorporate some of the IOM findings to strengthen the 510 (k) process, including clarifying when manufacturer changes to a 510(k)-cleared device already on the market warrant a new 510(k) submission.