• Organization: U.S. Department of Health & Human Services
• Updated: 2011-02-10

Provides information to the public on postmarket requirements and commitments. The phrase postmarket requirements and commitments refers to studies and clinical trials that sponsors conduct after...

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• Organization: U.S. Department of Health & Human Services
• Updated: 2013-11-01

The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic...

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• Organization: U.S. Department of Health & Human Services
• Updated: 2013-11-01

The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including Premarket Approvals (PMA),...

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