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3/11/2015 to 3/12/2015
When: March 11-12, 2015
Where: Crowne Plaza Cabana Hotel
4290 El Camino Real
Palo Alto, California  94306
United States
Presenter: Medical Device Manufacturers Association (MDMA)
Contact: Sheri DeVinney

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Join MDMA’s popular TWO day FDA Forum on March 11-12, 2015 in Palo Alto, CA. This conference will focus on unique insights and strategies to govern the 510(k) and PMA regulatory pathways. This is a great way for companies considering submitting a 510(k) or PMA to get the tools they need to prepare successful submissions.


Top FDA Speakers Include:

William Maisel, MD, MPH
Deputy Center Director for Science and CDRH Chief Scientist

Barbara Zimmerman
Deputy Director, CDRH, Office of Device Evaluation

Owen Faris *via teleconference
Clinical Trial Director, ODE

Murray Sheldon *via teleconference
Associate Director for Technology and Innovations, CDRH

Topics Include:

  • Navigating Today’s 510(k) Program
  • Clinical Trial Considerations
  • The Growing DeNovo Program
  • PMA Review Considerations
  • MDUFA Independent Assessment Update
  • UDI Implementation

The conference will also have a panel of industry experts for the interactive session, "Applying Lessons Learned/Case Studies.”

Registration Fees:


Day One-PMA/510(k) Workshop Only:

MDMA member: $295
MichBio member: $395 (enter code “state”)
Nonmember: $495

Day Two-FDA Reform: 2012 & Beyond Only:


MDMA member: $295
MichBio member: $395 (enter code “state”)
Nonmember: $495

BOTH Days:


MDMA member: $495
MichBio member: $595 (enter code “state”)
Nonmember: $895

This seminar is pre-approved by RAPS as eligible for up to 6 credits towards a participant's RAC recertification upon full completion.

[Visit event website for more information]

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