Description

One of the most difficult aspects of getting a medical device to the U.S. market is KNOWING WHERE TO BEGIN i.e., what are the steps for marketing and in what order they are to be taken. Essentially, medical devices are subject to the general controls of the Federal Food Drug & Cosmetic Act.

We look forward to seeing you for this important and information-packed workshop with FDA's regulatory experts.  Meet our presenters and have your questions answered in an informal and interactive day-long session on a topic that is vital to the successful marketing of your medical device(s) in the U.S.

Speakers

Yunk Pak
Chef, Regulatory Assistance Branch
Division of Small Manufacturers, International and Consumer Assistance
Center for Devices and radiological Health
FDA

Rodrigo C. Perez, M.S.E.
Consumer Safety Officer
Division of Small Manufacturers, International and Consumer Assistance
U.S. Food and Drug Administration (FDA)
Office of Communications, Education and Radiation Programs
Center for Devices and Radiological Health (CDRH)

Who should attend?

• Regulatory affairs associates of all levels and anyone interested in the FDA regulation.

Registration Information

Non-members fee :  $85 plus taxes

MEDEC members fee :   $60 plus taxes

Cancellation Policy:  Cancellations must be received in writing by August 31, 2010 to qualify for a refund. Substitutions are permitted.  Failure to show will result in full fee charge. Registrations become effective only when payment has been received by MEDEC.  Payment must be receivedprior to the start of the conference.

Collaborators