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FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making
Date:8/4/2010

lude its use as a predicate and also consider whether additional authority is needed.
  • Both reports recommend that CDRH build upon public databases to include meaningful, up-to-date information that supports good decision making and promotes the safe use of devices. This could be accomplished by improving the current 510(k) database so that it includes summaries of FDA review decisions, current labeling and photos. In addition, the science report recommends that CDRH build upon the existing transparency website to provide more immediate information on how devices are regulated.

  • For more information:

    CDRH Preliminary Internal Evaluations:

    http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/default.htm

    CDRH Device Approvals and Clearances: 510(k) Clearances: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/default.htm

    Media Inquiries: Dick Thompson, 301-796-7566, dick.thompson@fda.hhs.gov


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    SOURCE U.S. Food and Drug Administration
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