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For many years, FDA's Center for Devices and Radiological Health (CDRH) has provided information to help industry comply with FDA regulations.

In support of the FDA Transparency Initiative, CDRH is providing additional information to help the public understand its processes and decisions. The new information includes:

information about regulatory decisions and the rationales for those decisions
descriptions of regulatory processes
data to support CDRH actions and public health activities

The list below contains information that CDRH is releasing for the first time. The additional pages on this Web site provide information about CDRH processes and decisions.

Recently Added Information

Topic	Date
Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes	10/09/12
Evaluation of Automatic Class III Designation (De Novo) Summaries	08/23/12
515 Program Initiative	02/17/12
FDA Medical Device 2010 Quality System Data (PDF - 117KB)	05/23/11
Post-Approval Study Database Updated with new data fields describing the study Protocol
Investigational Device Exemption (IDE) Pivotal Study Summary Form (Updated)	10/27/10
CDRH Inspections Database	09/30/10
FDA Summary of Safety and Effectiveness Data (SSED) Clinical Section Checklist	08/03/10
Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers	07/08/10
Health Hazard Evaluations (HHEs) and Health Risk Assessments (HRAs)	07/01/10
Guidance for Industry, Third Parties and Food and Drug Administration Staff - Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program	03/19/12
Adverse Event Flowchart (PDF - 247KB)	05/19/10
Agenda and Materials From April 20, 2010 FDA Performance Report	04/20/10
Total Product Life Cycle (TPLC)	04/19/10
Nationwide Evaluation of X-Ray Trends (NEXT) Computed Tomography Dataset	04/19/10
Overview of Medical Devices and Their Regulatory Pathways	04/19/10
Radiation-Emitting Products Industry Assistance: Walk-through	04/19/10

Key CDRH Databases and Resources

Other Transparency Resources

We encourage your feedback on this information and would welcome your suggestions for additional information you would like to see.

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CDRH Transparency

Recently Added Information

Key CDRH Databases and Resources

Other Transparency Resources

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