MDMA's FDA Forum
MDMA's FDA Forum
PMA/510(k) Workshop & FDA Reform: 2012 and Beyond
MDMA's FDA Forum
Wed, 03/21/2012 - 8:00am - Thu, 03/22/2012 - 5:00pm
Cypress - A Kimpton Hotel
10050 South De Anza Blvd
Cupertino, CA 95014

(please view the accommodations link to take advantage of the MDMA Discounted rate)

Two-Day Conference

PMA/510(k) Workshop & FDA Reform: 2012 and Beyond

 

This seminar is pre-approved by RAPS as eligible for up to 6 credits towards a participants RAC re-certification upon full completion.

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MDMA has expanded this popular seminar to TWO days, and will focus on unique insights and strategies to govern the 510(k) and PMA regulatory pathways, as well as what changes may come as a result of FDA reform efforts. Presentations will be made by leading FDA attorneys, industry representatives and FDA officials.

This Seminar will Cover:

  • Formatting and the Necessary Content for a 510(k)
  • PMA Review Strategies and Communications
  • Clinical Trial Considerations and Compliance Oversight
  • How to Avoid Common Mistakes and Roadblocks
  • Potential Impact, Proposed changes to the Premarket Review Process

The program will provide valuable insight from a variety of perspectives and give companies considering submitting a 510(k) or PMA in the future the tools they need to prepare successful submissions.