US FDA plans overhaul of decades-old medical device system

The system targeted by the actions generally allows manufacturers to launch new products based on similarities to decades-old products, not new clinical testing.

By: Reuters
Washington | Updated: November 26, 2018 10:27 PM IST

1 min read

US FDA plans overhaul of decades-old medical device system

The Food & Drug Administration campus. (AP Photo/Andrew Harnik, FILE)

US health officials say they plan to overhaul the nation’s decades-old system for approving most medical devices, which experts have long criticized for failing to catch problems with risky implants and medical instruments.

The Food and Drug Administration announced plans Monday 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 new products based on similarities to decades-old products, not new clinical testing.

The FDA’s pledge came one day after the publication of a global investigation into medical device safety by more than 50 media organizations, including The Associated Press. The probe, led by the International Consortium of Investigative Journalists, analyzed more than 8 million device-related health records, including death and injury reports and recalls.

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