Latest FDA Changes to the Process Bullet Proof 510k - 2017

Overview:  

The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. 

Objectives:

    Know the differences between the Traditional, Special and Abbreviated submissions

    Understand Substantial Equivalence and how it is applied

    Who is required to submit the application to FDA 

Who Will Benefit:

This course is appropriate to those involved in all aspects of the premarket notification, i.e., 510(k) process on behalf of medical device and In Vitro Diagnostic manufacturers.

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: support@compliance4All.com

Speaker Profile:

David R. Dills,Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape.