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MassMEDIC Hears Top FDA Official On Agency’s New Initiative For Medical Device Safety

Boston Scientific Safety Officer Speaks on Company’s Best Practices in Device Monitoring

Boston, Mass. (December 1, 2006) – Dr. Susan Gardner, Director of the FDA’s Office of Surveillance and Biometrics Center for Devices and Radiological Health (CDRH), today detailed the FDA’s new action plan to overhaul and strengthen the way it monitors the safety of medical devices after they reach the marketplace. The keynote speaker at a special event this morning hosted by the Massachusetts Medical Device Industry Council (MassMEDIC), Dr. Gardner is responsible for overseeing the implementation of this new initiative.

“Dr. Gardner provided important information on how FDA will change its post-market activities; important information for all medical device companies,” said Tom Sommer, president of MassMEDIC.  “Massachusetts medical device companies are among the nation’s leaders in developing and pioneering medical device technologies, we are eager to partner with the FDA to ensure that medical devices are as safe and effective as possible.”

The CDRH’s Postmarket Transformation Leadership Team, formed in January to create plans to strengthen its postmarket program for medical devices, recommended the new initiative which focuses on four main areas including: enhancing the center’s culture of collaboration; developing world-class data systems; enhancing risk/benefit communication efforts; and collaborating on improved enforcement strategies and outcomes.

The MassMEDIC seminar, FDA UPDATE: Current Trends in Postmarket Surveillance, also featured other officials from the FDA who provided insight on the ongoing efforts to promote postmarket surveillance, and a representative from Boston Scientific Corporation, who shared perspective about its best practices in device monitoring.  They included:

Mutahar Shamsi, Director of Compliance, FDA, New England District Office

William Boivin, Supervisory Consumer Safety Officer, Medical Devices, FDA,  New England District Office

Sheila M. Hemeon-Heyer, JD, RAC, Vice President, Global Regulatory Affairs, Boston Scientific Corporation