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.

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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

Others Details

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