CDRH Transparency

Representation of transparency with a photo of two hands holding a transparent window frame in a blue sky with white clouds.

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
Evaluation of Automatic Class III Designation (De Novo) Summaries	01/18/17
Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes	05/17/16
Medical Device Recall Report, FY2003 to FY2012 (PDF - 818KB)	03/21/14
Overview of Medical Device Classification and Reclassification	12/17/13
Reclassification	12/17/13
515 Program Initiative	03/22/13
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
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
(Withdrawn) Guidance for Industry, Third Parties and Food and Drug Administration Staff - Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program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
CDRH Transparency: Total Product Life Cycle (TPLC)	04/19/10
Overview of Medical Devices and Their Regulatory Pathways	04/19/10
Radiation-Emitting Products Industry Assistance: Walk-through	04/19/10

About FDA

CDRH Transparency

Recently Added Information

Key CDRH Databases and Resources

Other Transparency Resources

Subscribe

More in CDRH Transparency

Resources for You