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

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

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 www.fda.gov/CDRHTransparency and let us know what you think.  Feedback provided will be used to improve and expand the website.

Afia Asamoah

Transparency Initiative Coordinator

  1. NorCal Gal
    April 24, 2010 at 12:12 pm

    I had a severe post-surgical complication that I’m convinced was related to a subcutaneous local anesthetic pump and/or its contents, but that’s not how the ER doc or hospitalist classified my visit – one in which they were admittedly not familiar with the equipment. I believe I would have been one of the 700+ statistics had they not removed the pump, which they did only after failing to determine any other cause of the extreme hypotension & bradycardia.
    Is anyone investigating or tracking near misses?

  2. Nirmal singh
    May 5, 2010 at 2:54 pm

    The U.S. Food and Drug Administration launched the Center for Devices and Radiological Health (CDRH) Transparency Web site today as part of the agency’s transparency initiative. The site will provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data that provide the rationale for agency actions.
    Thanx

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    May 8, 2010 at 7:53 pm

    It’s good when we can see transparency..Thanks a lot!

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      I write a comment when I appreciate a article on a website or if I have
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    Not only is transparency valued by the public when it comes to the approval or disapproval of medical devices but the fact that the public is allowed to give input is extremely valuable in opening communication and coming up with relevant solutions.

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  7. December 20, 2010 at 9:26 pm

    An excellent addition to the FDA site. Transparency regarding medical devices is very important and needed.

  8. September 20, 2011 at 7:48 pm

    Here’s another great action that will certainly contribute for improve transparency. If consumers trust FDA this will be better for all. You’re doing a great job!

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