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Shuren Touts Pre-Market Benefits Of Planned National Post-Market Strategy

CDRH is drafting a national comprehensive post-market strategy, due out this spring. While a principle goal is catching safety problems earlier, Jeffrey Shuren hopes the plan will ultimately make data collection less burdensome for industry, both in the pre-market and post-market stages.

The device center plans to propose a new national comprehensive post-market surveillance strategy this spring.

CDRH Director Jeffery Shuren says the goal will be to establish an infrastructure that both FDA and industry can leverage, not only to make post-approval data collection more effective and less burdensome

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