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  1. CDRH Transparency

Overview of CDRH Transparency

The Food and Drug Administration (FDA) formed the Transparency Task Force to develop recommendations for making useful and understandable information about FDA activities and decision making more readily available to the public in a timely manner and in a user-friendly format.

In support of the Agency’s Transparency Initiative, CDRH launched this Transparency Web site to provide meaningful and timely information about the products it regulates and the decisions it makes.

What we have done already

For many years, CDRH has provided information to help industry comply with FDA regulations. The following resources provide the basic requirements that must be met and information about product approval and clearance.

CDRH also provides information about adverse events of medical device and radiation-emitting products after they are marketed.

What's New?

CDRH is providing additional information about its processes, data it has collected, and decision making and educational resources.

What's Coming?

In the coming months, we will provide more information about:

  • CDRH Research
  • Premarket Approval and 510(k) Decisions

Please provide your feedback on our Transparency Initiative and ideas for future content.

Resources for You

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