Medical Device Industry, Advocates Weigh In On Proposed Expedited Approval Process
The Hill's Healthwatch blog reports that consumer groups and device makers are weighing in on a proposal to expedite the approval process for some medical devices. "While the Advanced Medical Technology Association (AdvaMed) argues for modernizing the process while arguing that it's safe, Public Citizen counters that it 'has failed to consistently protect the public health.' The comments come as the Food and Drug Administration is considering more than 60 changes to the expedited approval process for low- and moderate-risk devices, known as pre-market review or 510(k)." A consumer group says the FDA should do more to "keep dangerous and ineffective medical devices from the market" (Pecquet, 10/5).CQ HealthBeat: "The [FDA] proposed significant changes in August, which were outlined in two lengthy documents. The ideas resulted from concerns over whether the current review program takes a stringent enough approach to evaluating the safety and effectiveness of products and whether a lack of consistency at the agency is causing uncertainty about the process" (Adams, 10/5).
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