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    FederalPremarket Notifications (510(k)s)U.S. Department of Health & Human Services — Medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first...
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    FederalFDA Recognized Consensus StandardsU.S. Department of Health & Human Services — This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information...
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    FederalTotal Product Life Cycle (TPLC)U.S. Department of Health & Human Services — The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases...
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    FederalCDRH Inspections DatabaseU.S. Department of Health & Human Services — The CDRH Inspections Database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present.
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    FederalPOCA -Phonetic Orthographic Computer AlgorithmU.S. Department of Health & Human Services — POCA is a software that produces a data set used internally to assess the safety, and feasibility of proposed proprietary drug names. FDA product name safety...
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    FederalX-Ray Assembler DataU.S. Department of Health & Human Services — Federal regulations require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly. This database...
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    FederalApproved Risk Evaluation and Mitigation StrategiesU.S. Department of Health & Human Services — The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to...
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    FederalHydrolyzed Vegetable Protein Containing Products RecallsU.S. Department of Health & Human Services — This list includes products subject to recall in the United States since February 2010 related to hydrolyzed vegetable protein (HVP) paste and powder distributed by...
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    FederalMammography FacilitiesU.S. Department of Health & Human Services — The Mammography Facility Database is updated periodically based on information received from the four FDA-approved accreditation bodies: the American College of...
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    FederalFDA Pistachio Product Recalls WidgetU.S. Department of Health & Human Services — Contains data for FDA pistachio product recalls since March 2009.
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    FederalShell Egg RecallsU.S. Department of Health & Human Services — Epidemiologic investigations conducted by health officials in California, Colorado, and Minnesota revealed several restaurants or events where more than one person...
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    FederalFDA Data InventoryU.S. Department of Health & Human Services — An inventory of all FDA Datasets
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    FederalFDA Peanut-Containing Product RecallU.S. Department of Health & Human Services — The FDA Peanut-Containing Product Recall widget allows you to browse the Food and Drug Administration (FDA) database of peanut butter and peanut-containing products...
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    FederalCFSAN Knowledge Management SystemU.S. Department of Health & Human Services — This system supports the Information Center's Help Desk capabilities, and reports can be exported.
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    FederalPost-Approval StudiesU.S. Department of Health & Human Services — The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a...
