Events for Food and Drug Administration (FDA)

CDRH's Number–One Priority — Are You Prepared?

Sign up your entire team to listen in and discover:

* The nuts and bolts of the FDA’s postmarket surveillance authority under the FDAAA
* How postmarket surveillance compares with postapproval studies
* When and how postmarket surveillance can be imposed
* Three pitfalls to avoid when preparing for postmarket surveillance
* Strategies for meeting regulatory expectations for complying with postmarket surveillance requirements
* 10 critical details to include in a postmarket surveillance plan
* The role of postmarket surveillance in the bigger picture of the FDA’s Postmarket Transformation Initiative
* Potential consequences of noncompliance
* Four ways postmarket surveillance impacts other key FDA compliance requirements

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