Action urged on medical device approval

WASHINGTON, July 29 (UPI) -- U.S. regulators should develop a new regulatory framework to replace a 35-year-old clearance process for medical devices, the National Academy of Sciences says.

The current process, known as 510(K) and put in place by congressional action in 1975, lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of many devices and cannot be transformed into one, the report by the academy's Institute of Medicine said in a report.


The Food and Drug Administration's finite resources would be better utilized in developing a new framework that uses both premarket clearance and improved post-market surveillance to provide reasonable assurance of the safety and effectiveness medical devices throughout the duration of their use, the report said.

"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 report committee chair David Challoner, vice president for health affairs at the University of Florida, Gainesville.

Under the 510(K) process, new devices are cleared if they are sufficiently similar to comparable products that were previously cleared or were on the market prior to 1975 when the 510(k) process was inaugurated.


However, the majority of the devices used as the basis for comparison were never reviewed for safety or effectiveness and the process cannot assure that devices reaching the market are safe and effective, the committee concluded.

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