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  6. CDRH Transparency: Premarket Submissions
  1. CDRH Transparency

CDRH Transparency: Premarket Submissions

Before a device can be marketed to the public, CDRH requires submissions of data to ensure safety and effectiveness. Depending on the classification of a device or on the need for a clinical trial, the submitted data is entered into one of several databases.

Decision Summaries, Databases, and Premarket Reports

Premarket Programs and Processes

Resources for You


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