December 2006
|
|
|
|
|
|
|
December 2006 |
|
|
|
|
|
|
|
| |
|
|
||
|
New
England, National Post-Market Surveillance Strategies Discussed at FDA
Update
On December 1, more than 140 MassMEDIC members gathered to hear representatives from the national and regional offices of the U.S. Food & Drug Administration discuss new initiatives in medical device compliance and post-market surveillance. Captains Mutahar Shamsi and Bill Boivin of the New England District Office provided a year-upon-year comparison of the Office’s monitoring, inspection, and corrective actions in the device industry. Captain Boivin also updated the audience on the Office’s 2006 accomplishments, including a number of advanced certifications obtained by District staff and continued improvement in the third-party accreditation program. The complexities of post-market surveillance were presented from both
the regulatory and industry perspective, with Susan Gardner, PhD, representing
the Office of Surveillance and Biometrics at the CDRH, and Sheila Hemeon-Heyer,
Vice President of Global Regulatory Affairs, presenting on behalf of Boston
Scientific. Dr. Gardner provided an overview of the FDA’s efforts
to address rising adverse events and recalls through its Postmarket Transformation
Initiative. According to Dr. Gardner, among the specific areas of focus
for the Initiative are: Sheila Hemeon-Heyer discussed the challenges of developing and maintaining an effective postmarket surveillance in a global organization with multiple locations, suppliers and products. To approach these issues, Boston Scientific has created a culture that ingrains responsibility for product quality throughout the organization. The company has also built an integrated system that utilizes registries, tracking systems and protocols to maximize the data from postmarket monitoring. For more information and to review the presentations from this seminar
please click here. |
 |
 |
 |