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

BayBiotech.NET
On April 19th, 2010 FDA launched he Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative.
The 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 as well as a step-by-step guide for manufacturers of radiation-emitting products to assist with the regulatory process.

To read more about it, click here.

Comments

  1. software quality assuranceJune 9, 2010 at 10:29 AM

    It is very helpful to the people who studied clinical studies. Thanks for sharing the informative post.

    ReplyDelete

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