CDRH Aiming to Toughen Stance on Use of Old Predicate Devices

Amid calls from devicemakers to improve its policies on predicate devices and promises from CDRH to do so, the center is beginning to clarify changes that may be in the works as part of its 510(k) overhaul. One of the reforms being considered by CDRH would eliminate the use of devices that have been on the market for decades as predicates, Josephine Bautista, a consumer safety officer in CDRH’s Office of In Vitro Diagnostic Device Evaluation and Safety, said. “You will not have a device today that uses a predicate from 20 years ago,” she said. “That’s just not going to happen.”
Devices & Diagnostics Letter