AAMI University Webinar

New FDA Tools For Medical Device Adverse Event Reporting

Wednesday, February 4, 2015 @ 12:00 Noon Eastern

FDA officials will provide an overview of the MedWatch Safety Information and Adverse Event Reporting Program. You will learn how to submit voluntary and mandatory adverse event reports to the agency and hear about new tools that are available to make voluntary and mandatory adverse event reporting easier.

Attend this free webinar as we discuss medical device reporting and its regulatory framework. Plus learn about proposed changes to the MedWatch forms.

Program Objectives:
– Identify product problems you can report to the FDA through voluntary and mandatory reporting pathways
– Discuss new MedWatch reporting tools and learn about proposed changes to existing tools and forms
– Examine how you can receive safety information from FDA through the MedWatch program

Stephanie Joseph, MPH, Health Programs Coordinator
Food and Drug Administration
William C. Maloney, CDRH
Food and Drug Administration

CLICK HERE for additional information and registration.


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