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FDA Revises Postmarket Surveillance Guidance

CDRH has consolidated its postmarket surveillance guidances into a single document to make it easier to access information. The new document, released today, mostly takes the form of a FAQ. Issues covered include the policy criteria CDRH uses to determine whether to impose postmarket surveillance, the responsibilities of the various review team members, and notification issues. With postmarket issues becoming more of a priority at CDRH, this document should come in handy.
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