FDA to Update Medical Device Approvals Process

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Revised process will ensure new medical devices meet safety and effectiveness standards
Revised process will ensure new medical devices meet safety and effectiveness standards

(HealthDay News) -- A major update of the United States' system for approving medical devices was announced yesterday by the Food and Drug Administration.

Experts have long criticized the decades-old process for its failure to identify problems with risky medical implants and instruments, CBS News/Associated Press reported. The revised process will ensure that new medical devices meet safety and effectiveness standards, according to the FDA.

Currently, medical device makers are generally allowed to introduce new products based on similarities to decades-old products, without having to conduct new clinical trials in patients, CBS/AP reported. "We believe that newer devices should be compared to the benefits and risks of more modern technology," FDA Commissioner Scott Gottlieb, MD, said in a statement. Some of the proposed changes could take years to implement, according to CBS/AP.

The FDA's announcement came a day after the release of findings from an investigation into medical device safety worldwide that was led by the International Consortium of Investigative Journalists and included more than 50 media organizations. It found that more than 1.7 million injuries and nearly 83,000 deaths suspected of being caused by medical devices were reported to the FDA over a 10-year period, CBS/AP reported.

References

FDA vows to overhaul decades-old system for approving medical devices. CBS/AP News; November 26, 2018 Article

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA's 510(k) program to advance the review of the safety and effectiveness of medical devices. FDA; November 26, 2018 (news release)

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