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  1. Center for Devices and Radiological Health

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 additional pages on this Web site provide information about CDRH processes and decisions.


Topic

  Date
Evaluation of Automatic Class III Designation (De Novo) Summaries 09/23/21
Medical Device Accessory Classification Request Granting Decisions 08/14/20
CLIA Waiver by Application Decision Summaries 09/29/17
Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes 03/20/17
Overview of Medical Device Classification and Reclassification 12/17/13
Reclassification 12/21/16
515 Program Initiative 03/22/13
CDRH Transparency: Total Product Life Cycle (TPLC) 09/06/18
Radiation-Emitting Products Industry Assistance: Walk-through 04/19/10

 

CDRH Databases


Performance Data and Transparency Resources


Resources for You



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