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.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 01 July 2011 | By Mike Ronnigen, RAC,
Submitting a Premarket Approval Application (PMA) for a Class III medical device to the US Food and Drug Administration (FDA) initiates a cascade of activities that requires the company to be operating at peak performance. Once the PMA is submitted, it is logged and issued to the Division of Bioresearch Monitoring (DBM) for assignment of initial review to determine whether it is fileable.