The Journal Gazette
Tuesday, November 27, 2018 1:00 am

New medical device rules

FDA overhauling outdated system for safety concerns

MATTHEW PERRONE | Associated Press

WASHINGTON – U.S. health officials said Monday they plan to overhaul the nation's decades-old system for approving most medical devices, which has long been criticized by experts for failing to catch problems with risky implants and related products.

The Food and Drug Administration announced plans aimed at making sure new medical devices reflect up-to-date safety and effectiveness features. The system targeted by the actions generally allows manufacturers to launch products based on similarities to decades-old products, not new clinical testing in patients.

The FDA's move came one day after the publication of a global investigation into medical device safety by more than 50 media organizations, including The Associated Press. Led by the International Consortium of Investigative Journalists, the group found more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices had been reported to the FDA over a 10-year period.

“We believe that it's time to fundamentally modernize an approach first adopted in 1976,” FDA Commissioner Scott Gottlieb said in a statement, noting that the changes under consideration would push companies to compare their devices to more up-to-date technology.

On Twitter, he described the proposal as “the most significant modernization” of the medical device review process in a generation.

Some of the reforms proposed by the FDA could take years to implement and potentially include new guidelines and regulations for manufacturers, and the most substantive changes could require action by Congress.

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