FDA Evaluating Effectiveness of CDRH Notifications

The FDA is determining the clarity and timeliness of two notifications issued by CDRH to healthcare practitioners that convey potential device risks. CDRH communicates possible risks posed by devices through two publications, the Public Health Notification (PHN) and the Preliminary Public Health Notification (PPHN). The PHN is used when CDRH has data to help healthcare providers make informed clinical decisions about the use of a device. The PPHN conveys the same sort of information but under different circumstances, according to a notice published last week in the Federal Register. Comments on the FDA’s information collection are due by Oct. 23.
Devices and Diagnostics Letter