FDA Requiring Safety and Effectiveness Data on Certain Class III Devices
BY DAVID KRESSEL, APRIL 9, 2009
The FDA announced yesterday that it would be requiring companies who manufacture 25 specific devices marketed prior to 1976 to submit safety and effectiveness data so they can gauge product risk. The agency says this is in response to January's GAO recommendations regarding approval and reclassification of certain class III devices. If the named devices are found to be high risk and without proof of safety and efficacy, companies will be required to submit a PMA for the product.
1976 is, of course, the year that the Food, Drug, and Cosmetic Act went into effect, mandating that all devices be reviewed by the FDA. Since 1976, the 25 devices in question have been classified as class III and subject to PMA approval, though FDA never requested these PMAs.
The orthopedic devices on the list are cemented and uncemented metal-on-metal hips and "certain uses" for pedicle screw systems. The uses in question for pedicle screws appear to be treatment for degenerative disc disease and spondylolisthesis other than grade 3 and 4 spondylolisthesis at L5-S1 or degenerative spondylolisthesis with evidence of neurologic impairment. There are thousands of metal-on-metal hip devices sold each year, and while there are hundreds of thousands of pedicle screws sold each year, they are mostly cleared for sale with an indication for use that causes them to be class II devices, and not the uses in question.
The dental devices on the list were endosseous dental implants (blade form) and mandibular condyle prostheses (temporary implants). These products are currently sold in very limited amounts.
Devicemakers have 120 days to submit the data.
