FDA Orders Makers of Older Medical Device to Provide More Updated Effectiveness Data

The Food and Drug Administration is requiring makers of two dozen medical devices sold before 1976 to provide the agency with information about whether the devices are still effective or should undergo stricter, more up-to-date safety FDA reviews.

Metal replacement hips, screws used in spinal surgery, and dental implants are among the older devices covered by the new FDA order. The agency previous has allowed older Class III medical devices to remain in use without the same thorough review and testing that newer medical devices face.

Class III medical devices are considered the most potentially dangerous products and are exposed to the toughest FDA reviews. It is suspected that older medical devices approved before the FDA subjected them to stricter review may be not as effective or as safe as more modern devices.

Congressional Watchdog Criticizes FDA Policy

The Government Accountability Office, the watchdog arm of Congress, recently criticized the FDA’s policy of allowing older medical devices to slide by stricter safety reviews and urged the agency to quickly deal with the issue. The FDA order to 25 makers of medical devices is a response to that critique.

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