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FDA should invest in developing a new regulatory framework to replace flawed 510(k) medical device clearance process
Date:7/29/2011

et testing that drugs must go through, and even that more rigorous process cannot ensure that every safety problem is caught. Given that both patients and the industry desire a streamlined process to get new devices to market in a timely fashion, it is essential to have robust postmarket surveillance of these products, the report says.

However, the committee found substantial weaknesses in current postmarket oversight of devices and it heard from FDA that the agency faces limitations on its authority to address problems with products on the market. FDA should analyze what barriers hamper the efficient and effective use of its regulatory tools and identify ways to overcome them, the report says. If necessary, Congress should pass legislation to remove barriers to FDA's use of postmarket regulatory authority. The agency also should develop and implement a comprehensive strategy to collect, analyze, and act on information about devices' performance after clearance.

FDA should promptly complete its task of determining how to handle 26 device types classified as "high risk" that are allowed to reach market through the 510(k) process. FDA can either reclassify these types into a lower risk category if warranted or require them to go through the PMA process. Devices considered substantially equivalent to products in these 26 categories continue to be cleared for the market through the 510(k) process.


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Contact: Christine Stencel
news@nas.edu
202-334-2138
National Academy of Sciences
Source:Eurekalert

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