Most medical devices, including many implants, are being cleared for sale by the FDA without tests for safety or effectiveness, KFF Health News reported Dec. 21.
Instead of proving safety or effectiveness, many manufacturers are using the 501(k) clearance process, which requires them to prove only "substantial equivalence" to a product already on the market.
A 2011 Institute of Medicine report concluded that 510(k) was "not intended to evaluate the safety and effectiveness of medical devices" and said "a move away from the 510(k) clearance process should occur as soon as reasonably possible."
No changes have been made in that time, and the FDA clears about 3,000 low- to moderate-risk devices every year through the 510(k) review. Devicemakers pay a $22,000 FDA fee for the 510(k) review, as opposed to nearly $500,000 per device for the stricter premarketing requirements that about 30 devices are approved through each year, according to FDA data.
In response to questions from KFF Health News, the FDA said it "continues to believe in the merits of the 510(k) program and will continue to work to identify program improvements that strengthen the safety and effectiveness of 510(k) cleared devices."
Many physicians and patients do not realize devices cleared for sale typically do not undergo clinical trials to establish safety. And once those devices hit the market, the FDA struggles to track malfunctions, deaths and injuries, the report said.