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.

• Guidance
• Device Advice
• CDRH Learn
• PMA Database
• 510(k) Database

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

• The Manufacturers and User Facility Device Experience (MAUDE) Database
• Medical Device Safety
• Class 1 Recalls
• Alerts

What's New?

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

• 180 day Premarket Approval (PMA) supplement summary review memos
• Total Product Life Cycle (TPLC) reports, containing information by product about clearances and approvals, adverse events, and recalls
• A clinical trial database from Premarket Approvals
• Investigational Device Exemption (IDE) review template
• A general overview of the premarket process

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.