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Postmarket Issues Still Top Schultz' Agenda

When CDRH Director Daniel Schultz addressed the AdvaMed annual meeting last week, everyone expected a presentation heavy on postmarket issues. He did not disappoint.

Among CDRH's priorities for FY 2006, he said, are to "increase our ability to identify, analyze, and act on postmarket information" and to "increase communication of risk/benefit issues to all of our stakeholders." Specific tasks, he said, include strengthening Condition-of-Approval studies, improving the MedSun program, boosting the center's automated information systems, and focusing on risk-based inspections. Then there is the Medical Device Postmarket Transformation Initiative, which takes a more macro perspective, looking at how CDRH can change its culture and systems to better manage postmarket information. These are extremely tough challenges, but Schultz isn't the type to shy away from them. Neither should you.

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