April 9th, 2009
FDA orders new approvals on old medical devices
Medical devices whose Class III approvals were grandfathered in during the 1970s must now go through the process of proving their safety.
The industry representing the makers, AdvaMed, is not upset. A press statement expressed the hope that some might be reclassified following the review into less-risky categories, making them more marketable.
The FDA has long had three classes of device, from non-risky Class I bandages to very-risky Class III pacemakers. Back in 1976 Congress asked the agency to classify the old gear based on this risk profile.
For 27 types of products, nothing has happened for a generation. Yet last year, in Riegel vs. Medtronic, the Supreme Court ruled that FDA device approvals trump a patient’s rights to sue.
So what we’re left with is risky devices that were never tested but lie beyond the reach of civil law because courts claim the untested approval is binding.
The new round of tests will close the loophole.
Dana Blankenhorn has been a business journalist since 1978, and has covered technology since 1982. He launched the Interactive Age Daily, the first daily coverage of the Internet to launch with a magazine, in September 1994. See his full profile and disclosure of his industry affiliations.
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| 04/09/09
