522

 

WHAT:  Design, Tracking, Oversight, Review of studies mandated under section 522, Federal Food, Drug and Cosmetic Act

WHY: To ensure well-designed 522 postmarket surveillance studies, conducted effectively and efficiently in the least burdensome manner

WHEN: Since 2008

WHO: Division of Epidemiology , Office of Surveillance and Biometrics, CDRH

HOW: CDRH Internal Tracking System, PUBLIC WEBPAGE

LINK

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s