Federal regulators to check safety levels of 'legacy devices'

In a move that seems like it's been decades in the making, federal regulators announced that they would be checking the safety levels of risky medical devices. The move was spurred by a report issued in January by the Government Accountability Office that came down hard on the FDA's system of reviewing legacy devices--medical devices created before 1976. 

The legacy devices initially were allowed to hit the market without much testing. Congress stepped in, in 1976, ordering the FDA to reclassify older devices to determine which ones needed more testing before approval of new versions. It was a process the FDA failed to complete, and resulted in products such as external defibrillators and pacemaker components going untested; 27 devices in all went unexamined. 

According to FDA spokeswoman Mary Long, there is no timetable for the project's completion. "We have to review each device type separately," she said. "It will take some time." 

For more on this issue:
- check out this New York Times article [1]

Related Articles:
FDA investigated for improper review of medical devices [2]
FDA to tighten medical device safety regs [3]
FDA's medical approval process faces GAO scrutiny [4]