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New
FDA Proposal to Transform Agency’s Postmarket Surveillance Procedures
to be discussed at FDA Update Seminar on December 1
Please plan to join MassMEDIC on December 1 for an informative presentation
by Susan Gardner, Ph.D., Director of the Office of Surveillance and Biometrics
at CDRH, on the FDA’s Postmarket Transformation Initiative and its
recent proposal to overhaul the agency’s postmarket program for
medical devices. Dr. Gardner will address the FDA’s specific recommendations,
including:
• Creating a cross-cutting organizational structure within CDRH
to better integrate premarket, postmarket and enforcement efforts;
• Developing internal performance measurements to track the center's
handling of postmarket issues, such as recalls;
• Proposing mandatory use of electronic reporting for required adverse
event reports and revising the current system that records reported adverse
events for devices (the Manufacturer and User Facility Device Experience
Database or MAUDE system);
In addition, representatives of the New England District Office will provide
guidance on compliance directives and local procedures for addressing
adverse events. Sheila Hemeon-Heyer, Vice President of Global Regulatory
Affairs at Boston Scientific Corporation will address the company’s
efforts to improve its own postmarket surveillance program.
For more details and to register for this program,
please click
here.
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November 2006
