Sunday, October 20, 2019

Sunday, October 20, 2019

National Center for Health Research News

National Center for Health Research wants clearer information disseminated on device predicates

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.

FDA Reporter