About FDA

CDRH Transparency

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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

TopicDate
Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes 08/10/15
Evaluation of Automatic Class III Designation (De Novo) Summaries 07/09/15
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
CDRH Inspections Database 09/30/10
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
Overview of Medical Devices and Their Regulatory Pathways 04/19/10
Radiation-Emitting Products Industry Assistance: Walk-through 04/19/10

Page Last Updated: 08/10/2015
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