Pearl Pathways year end holiday hours

Our office will be closed for the holidays December 24th, 25th, 31st and also on January 1st.  There will be no IRB Board meeting the week of December 24th due to the holidays. We will resume IRB reviews the week of December 31st and hold a Board meeting on January...

CDRH Releases Device Review Performance Data

The Center for Devices and Radiological Health (CDRH) released a recent report that details how the agency believes their premarket approval (PMA) and 510(k) systems are performing after implementation of many actions. It has been nearly two years since the FDA...

FDA conducts nationwide survey

During the month of August, FDA conducted a nationwide 510(K) Pathway Med-tech Industry  Survey to measure perceptions of 510(k) Pathway, FDA’s performance, and FDA’s consistency. Nearly 200 of the 2707 people it was sent to responded to the survey, providing a 6.1%...