WASHINGTON — Federal regulators said Wednesday that that they would ask makers of some of the riskiest medical devices to prove that their products are safe and effective — a step that critics have said is long overdue.
In January, the Government Accountability Office issued a report scolding the Food and Drug Administration for failing for decades to fix its system for reviewing categories of devices that have been on the market since before the enactment of the medical device law in 1976.
Such legacy devices, as they are known, were originally allowed on the market with minimal testing. But in the 1976 law Congress instructed the F.D.A. to gradually reclassify these older devices and decide which ones needed extensive testing prior to approval of new versions and which ones did not.
The agency never finished that process, leaving 27 different types of devices unexamined. For decades, the F.D.A. has approved devices in these categories for sale without demanding rigorous tests showing that they work safely. Investigators for the accountability office stated that “it is imperative that F.D.A. take immediate steps” to fix its system for approving such devices, and the agency agreed.
The agency has already undertaken a review of two of these older device types, and it announced Wednesday that it was requiring makers of the other 25 types of devices to submit information to the agency within 120 days detailing the products’ safety and effectiveness.
Mary Long, an F.D.A. spokeswoman, said she could not predict how long the reclassification process for the older devices would take.
“It will really depend on the amount and quality of the information we get,” she said. “We have to review each device type separately. It will take some time.”
The New York Times
In January, the Government Accountability Office issued a report scolding the Food and Drug Administration for failing for decades to fix its system for reviewing categories of devices that have been on the market since before the enactment of the medical device law in 1976.
Such legacy devices, as they are known, were originally allowed on the market with minimal testing. But in the 1976 law Congress instructed the F.D.A. to gradually reclassify these older devices and decide which ones needed extensive testing prior to approval of new versions and which ones did not.
The agency never finished that process, leaving 27 different types of devices unexamined. For decades, the F.D.A. has approved devices in these categories for sale without demanding rigorous tests showing that they work safely. Investigators for the accountability office stated that “it is imperative that F.D.A. take immediate steps” to fix its system for approving such devices, and the agency agreed.
The agency has already undertaken a review of two of these older device types, and it announced Wednesday that it was requiring makers of the other 25 types of devices to submit information to the agency within 120 days detailing the products’ safety and effectiveness.
Mary Long, an F.D.A. spokeswoman, said she could not predict how long the reclassification process for the older devices would take.
“It will really depend on the amount and quality of the information we get,” she said. “We have to review each device type separately. It will take some time.”
The New York Times
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