This report, in U.S. News and World Report, says about 90% of the 4,000 applications for new medical devices through 510(k) are approved and reach the market every year.
That is 3,000 devices and the current program of approval for the market for products such as pacemakers and hip implants does not guarantee safety, according to a federal report by the Institute of Medicine. The highly anticipated report was highly critical of the current system of approval for market – the 510 (k) process of device approval – which was approved by Congress in 1976.
“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,” said the report author.
Read more here.