Posts Tagged ‘Medical Device’

FDA Launches Medical Device and Radiation-Emitting Product Transparency Web Site

April 19, 2010 30 comments

Today, the U.S. Food and Drug Administration (FDA) launched the Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative.  This site will provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data to support those decisions.

The new Web site is part of an ongoing effort within FDA to enhance communication and transparency.  This Web site makes available new information about CDRH’s decision-making processes and displays this information in a more user-friendly format.  The site includes new information such as:

  • basic information about medical devices and how FDA regulates those products
  • information about medical devices before and after the products are on the market, in a searchable database
  • information about the clinical studies and trials conducted to demonstrate the safety and effectiveness of certain medical devices
  • memos from FDA employees explaining the reasons for the agency’s decisions about medical device manufacturer requests to make a significant change in components, materials, design, specification, software, color additive, and labeling of a medical device
  • a step-by-step guide for manufacturers of radiation-emitting products to assist with the regulatory process

CDRH plans to add new information about premarket submissions, product performance & safety, compliance & enforcement, and science & research to this website monthly.

The Web site includes a feedback feature that will allow CDRH to collect input and suggestions from the public about the information provided.  Visit the CDRH Transparency Web site at and let us know what you think.  Feedback provided will be used to improve and expand the website.

Afia Asamoah

Transparency Initiative Coordinator


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