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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...

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Upcoming Events: FDA Basics Webinar on Indoor Tanning: Risks of UV Radiation,...

Do you have questions about Indoor Tanning? Did you know that FDA regulates tanning beds? As part of FDA Basics, FDA is hosting a webinar where you can learn more.  Featured speakers, Sharon Miller,...

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Materials Available from FDA Basics Webinar on “Indoor Tanning: Risks of UV...

Did you miss the FDA Basics webinar on “FDA’s Regulation of Tobacco Products”? Check out the “What’s New” box on the FDA Basics home page to download materials from the webinar.  We have posted a link...

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Upcoming Event: FDA Public Webinar About the “510(k) Premarket Review...

FDA recently published two preliminary reports conducted by the Center for Devices and Radiological Health (CDRH).  The first preliminary report is an assessment of the process used to review certain...

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FDA’s Center for Devices and Radiological Health (CDRH) Launches Inspections...

Yesterday, as part of the FDA Transparency Initiative, CDRH launched the ‘CDRH Inspections Database’.  The database provides information about medical device inspections that were the responsibility of...

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Additional Information About Post-Approval Studies Conducted with Medical...

FDA is taking steps to improve transparency about studies conducted with devices after approval.   The Center for Devices and Radiological Health (CDRH) has a program that oversees studies that are...

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