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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

confidence in their safety and effectiveness, the committee said. But 510(k) clearance does not determine a device to be safe or effective, the report adds.

"It's not clear that the 510(k) process is serving the needs of either industry or patients, and simply modifying it again will not help," said committee chair David Challoner, emeritus vice president for health affairs, University of Florida, Gainesville. "The 510(k) process cannot achieve its stated goals -- to promote innovation and make safe, effective devices available to patients in a timely manner -- because they are fundamentally at odds with the statutes that govern how FDA must implement the process. While current information is not adequate to immediately start designing a new framework, we believe the agency can get the necessary data and establish a new process within a reasonable time frame."

While the committee was neither charged with nor able to detail what a new framework should entail, the report discusses key attributes of an improved process, including that it be clear, fair, and predictable, and make use of regulatory tools and authority to ensure safety and effectiveness throughout the duration of a product's use. FDA should explore whether a modified version of its de novo process could replace the 510(k) process, the report says. The de novo process reduces the amount of information manufacturers must supply for devices deemed to be of low or moderate risk but that have no predicate devices against which to be compared. Changes would be necessary to fix problems that make the de novo process time-consuming and difficult to navigate before FDA initiates a pilot program.

No premarket regulatory system can guarantee that all medical devices will be completely safe and effective when they reach the market, the committee noted. Because of the differences between devices and drugs, it would be impractical for all devices to undergo the same sort of premark
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Contact: Christine Stencel
news@nas.edu
202-334-2138
National Academy of Sciences
Source:Eurekalert

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