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Recognized Consensus Standards: Medical Devices

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Standards Organization  Standard Designation NumberRecognition Number   KeywordsIncluded in ASCA?   Specialty Task Group Area  Product CodeRegulation Number   Date of Entry to Sort   Clear Form   

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510(k)s9De Novo10Medical Device Reports (MAUDE)11CDRH Export Certificate Validation (CECV)12CDRH FOIA Electronic Reading Room13CFR Title 2114CLIA15Device Classification16FDA Guidance Documents 17Humanitarian Device Exemption 18Medsun Reports19Premarket Approvals (PMAs)20Post-Approval Studies21Postmarket Surveillance Studies22Radiation-Emitting Products23Radiation-Emitting Electronic Products Corrective Actions24Recalls25Registration & Listing26Total Product Life Cycle27X-Ray Assembler28

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