The nonprofit National Center for Health Research (NCHR) said it believes the FDA should make patients aware that devices in the 510 (k) program have not been sufficiently tested on humans through trials, like drugs are tested before being put on the market.
“The amount of time that the device predicate has been on the market, while a significant factor, is less critical than the exact ways that the predicate is similar to the new device, and whether that predicate has undergone sufficient post-market clinical testing to give patients, physicians, and surgeons justifiable confidence that the device has benefits that are proven to outweigh the risks,” the NCHR recently wrote.
The NCHR said the FDA should also not allow recalled devices or devices with a large number of problems to be used as predicates.
The NCHR stressed the fact that the age of predicates is less important than the safety of the predicates, saying it wanted the FDA to remember the balance between innovation and safety.
