FDA: Requests for Feedback on Submissions Guidance

FDA issued a final guidance Requests for Feedback on Medical Device Submissions:The Pre-Submission Program and Meetings with Food and Drug Administration Staff” dated Feb 18, 2014 which supersedes the 1999 Pre-IDE Program blue book memo and draft of this gudance issued 2012. .The guidance is at the link attached and defines the various types of interactions that can be requested, what their purpose and scope are, as well as timeframes.

Upcoming Training

QSS Software Validation
Planned Instructors:  Brian Pate, John Murray
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)! 

Multi-Student Discounts as well!

Email training@softwarecpr.com
to receive discount

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.