Bullet Proof 510k – Latest Fda Proposed Changes to The

Nov 03, 17 Bullet Proof 510k – Latest Fda Proposed Changes to The

Bullet Proof 510k – Latest Fda Proposed Changes to The Process – Webinar By GlobalCompliancePanel

This 3 hour Webinar is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is usually a premarket submission designed to FDA to show that your gadget to be marketed reaches least as effective and safe, that is, substantially comparative, to a legally marketed gadget that’s not subject to PMA.

There are three types of Premarket Notification 510(k)s which may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) strategies were developed beneath the “New 510(k) Paradigm” to greatly help streamline the 510(k) review process. Product adjustments that could considerably affect safety and performance are at the mercy of 510(k) submission requirements under 21 CFR 807 and also design control requirements beneath the Quality Program (QS) regulation. Beneath the QS regulation, all Course II and III products and certain Course I devices must become designed in conformance to 21 CFR 820.30 Design Settings. FDA provides guidance which course will address important resources when coming up with critical decisions.

Objectives:

Detailed Agenda:

Introduction and Regulatory Background

The Process

Interactive Q&A, Wrap-Up and Adjourn

Who will benefit: This program is suitable to those involved with all areas of the premarket notification, i.e., 510(k) procedure with respect to medical gadget and In Vitro Diagnostic producers. It really is both a primer for staff not used to the FDA 510(k) process, or a fantastic refresher course for individuals who want to revisit the fundamentals and fundamentals for an improved understanding on how best to prepare and post your application to make sure regulatory and compliance achievement.

Those that will benefit includs:

Thursday, November 17, 2011

10:00 AM PST 01:00 PM EST

Price List:

Live : $245.00

Corporate live : $995.00

Recorded : $295.00

webinars@

Phone: 800-447-9407

Fax: 302-288-6884

David R. Dills, an unbiased Regulatory & Compliance Consultant with an increase of than 22 years of hands-on encounter and a proven background within the FDA regulated market, has an considerable regulatory and compliance history with Course I/II/III and IVD products and managing and managing actions within the global regulatory and compliance scenery. He manages quality, regulatory and compliance tasks with multiple competing priorities having a primary impact on site procedures and commercial possibilities and develops approaches for governmental authorization to introduce services to advertise, provides guidance and path on regulatory and compliance requirements and prepares/evaluations worldwide submissions/dossiers/technical documents and addresses requirements in the EU, Pacific Rim and The Americas concerning all areas of device commercialization and specifically FDA activities