Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 14 January 2015 | By Alexander Gaffney, RAC
The longtime director of the Center for Devices and Radiological Health's (CDRH) Office of Compliance, Steve Silverman, plans to leave the US Food and Drug Administration (FDA) next week to pursue other opportunities, press officials have confirmed to Regulatory Focus.
Silverman has been a central figure in CDRH's "Case for Quality," an effort to improve compliance among medical device manufacturers by focusing on common quality errors across the device industry. "We are consistently seeing a high volume of the same issues year after year," he noted in a 2013 presentation on the subject.
Silverman will be succeeded on an interim basis by Jan Welch, who now serves as the deputy director for Regulatory Affairs in CDRH's Office of Compliance. A search for a permanent successor to Silverman is now underway, FDA press official Jenny Haliski told Focus.
Tags: Office of Compliance, Steve Silverman, Leaving