美国FDA医疗器械中英文翻译

美国FDA医疗器械中英文翻译800总则GENERAL801标识LABELING803医疗器械报告MEDICALDEVICEREPORTING806医疗器械；改正与移动的报告MEDICALDEVICES;REPORTSOFCORRECTIONSANDREMOVALS807对器械的制造者与首次进口者的机构登记与器械列表ESTABLISHMENTREGISTRATIONANDDEVICELISTINGFORMANUFACTURERSANDINITIALIMPORTERSOFDEVICES808对州和地方医疗器械要求的联邦优先权的豁免EXEMPTIONSFROMFEDERALPREEMPTIONOFSTATEANDLOCALMEDICALDEVICEREQUIREMENTS（奥咨达医疗器械咨询）809人用体外诊断产品INVITRODIAGNOSTICPRODUCTSFORHUMANUSE810医疗器械召回权MEDICALDEVICERECALLAUTHORITY812试验用器械豁免INVESTIGATIONALDEVICEEXEMPTIONS813[预留的][Reserved]814医疗器械的上市前批准PREMARKETAPPROVALOFMEDICALDEVICES820质量体系规章QUALITYSYSTEMREGULATION821医疗器械跟踪要求MEDICALDEVICETRACKINGREQUIREMENTS（只专注于医疗器械领域）822上市后监视POSTMARKETSURVEILLANCE860医疗器械分类程序MEDICALDEVICECLASSIFICATIONPROCEDURES861性能标准制定程序PROCEDURESFORPERFORMANCESTANDARDSDEVELOPMENT862临床化学与临床毒理学器械CLINICALCHEMISTRYANDCLINICALTOXICOLOGYDEVICES864血液学与病理学器械HEMATOLOGYANDPATHOLOGYDEVICES866免疫学与微生物学器械IMMUNOLOGYANDMICROBIOLOGYDEVICES868麻醉学器械ANESTHESIOLOGYDEVICES870心血管器械CARDIOVASCULARDEVICES872牙科器械DENTALDEVICES874耳、鼻和咽器械EAR,NOSE,ANDTHROATDEVICES876胃肠病学-泌尿学器械GASTROENTEROLOGY-UROLOGYDEVICES878普通与整形外科器械GENERALANDPLASTICSURGERYDEVICES880普通医院与个人使用器械GENERALHOSPITALANDPERSONALUSEDEVICES882神经学器械NEUROLOGICALDEVICES884产科与妇科学器械OBSTETRICALANDGYNECOLOGICALDEVICES886眼科器械OPHTHALMICDEVICES888矫形外科器械ORTHOPEDICDEVICES890内科学器械PHYSICALMEDICINEDEVICES892放射学器械RADIOLOGYDEVICES895禁止的器械BANNEDDEVICES898电极铅线与患者电缆的性能标准PERFORMANCESTANDARDFORELECTRODELEADWIRESANDPATIENTCABLES第I分章―乳房造影质量标准法（SUBCHAPTERI―MAMMOGRAPHYQUALITYSTANDARDSACT）900乳房造影法MAMMOGRAPHY第J分章―放射学的健康（SUBCHAPTERJ―RADIOLOGICALHEALTH）1000总则GENERAL1002记录与报告RECORDSANDREPORTS1003缺陷与未能守法的通报NOTIFICATIONOFDEFECTSORFAILURETOCOMPLY1004电子产品的回购、修理或者置换REPURCHASE,REPAIRS,ORREPLACEMENTOFELECTRONICPRODUCTS1005电子产品的进口IMPORTATIONOFELECTRONICPRODUCTS1010电子产品的性能标准：总则PERFORMANCESTANDARDSFORELECTRONICPRODUCTS:GENERAL1020电离辐射发生产品的性能标准PERFORMANCESTANDARDSFORIONIZINGRADIATIONEMITTINGPRODUCTS1030微波与射电频率发生产品的性能标准PERFORMANCESTANDARDSFORMICROWAVEANDRADIOFREQUENCYEMITTINGPRODUCTS1040发光产品的性能标准PERFORMANCESTANDARDSFORLIGHT-EMITTINGPRODUCTS1050声波、次声波和超声波发生产品的性能标准PERFORMANCESTANDARDSFORSONIC,INFRASONIC,ANDULTRASONICRADIATION-EMITTINGPRODUCTS第K分章―[预留的]（SUBCHAPTERK―[RESERVED]）第L分章―根据由食品与药品管理局行政执行的某些其他法的规章（SUBCHAPTERL―REGULATIONSUNDERCERTAINOTHERACTSADMINISTEREDBYTHEFOODANDDRUGADMINISTRATION）1210根据《联邦进口乳法》的规章REGULATIONSUNDERTHEFEDERALIMPORTMILKACT1230根据《联邦腐蚀性毒物法》的规章REGULATIONSUNDERTHEFEDERALCAUSTICPOISONACT1240传染病的控制CONTROLOFCOMMUNICABLEDISEASES1250州际运输卫生INTERSTATECONVEYANCESANITATION1251-1269[预留的][Reserved]1270预期用于移植的人体组织HUMANTISSUEINTENDEDFORTRANSPLANTATION1271人体细胞、组织以及细胞的和基于组织的产品HUMANCELLS,TISSUES,ANDCELLULARANDTISSUE-BASEDPRODUCTS1272-1299[预留的][Reserved]第Ⅱ章―司法部毒品强制执行局（CHAPTERⅡ―DRUGENFORCEMENTADMINISTRATION,DEPARTMENTOFJUSTICE）1300定义DEFINITIONS1301管制物质的制造者、分销者和调剂者的登记REGISTRATIONOFMANUFACTURERS,DISTRIBUTORS,ANDDISPENSERSOFCONTROLLEDSUBSTANCES1302对管制物质的标识与包装要求LABELINGANDPACKAGINGREQUIREMENTSFORCONTROLLEDSUBSTANCES1303定额QUOTAS1304登记者的记录与报告RECORDSANDREPORTSOFREGISTRANTS1305令的格式ORDERFORMS1306处方PRESCRIPTIONS1307杂项MISCELLANEOUS1308管制物质的表SCHEDULESOFCONTROLLEDSUBSTANCES1309表I化学品的制造者、分销者、进口者和出口者的登记REGISTRATIONOFMANUFACTURERS,DISTRIBUTORS,IMPORTERSANDEXPORTERSOFLISTICHEMICALS1310列入表的化学品和某些机器的记录与报告RECORDSANDREPORTSOFLISTEDCHEMICALSANDCERTAINMACHINES1311[预留的][Reserved]1312管制物质的进口与出口IMPORTATIONANDEXPORTATIONOFCONTROLLEDSUBSTANCES1313前体与必要化学品的进口与出口IMPORTATIONANDEXPORTATIONOFPRECURSORSANDESSENTIALCHEMICALS1314-1315[预留的][Reserved]1316行政职能、规范和程序ADMINISTRATIVEFUNCTIONS,PRACTICES,ANDPROCEDURES第Ⅲ章―毒品控制政策办公室（CHAPTERⅢ―OfficeofNationalDrugControlPolicy）1400[预留的][Reserved]1401信息的公众可及性PUBLICAVAILABILITYOFINFORMATION1402强制性解密审查MANDATORYDECLASSIFICATIONREVIEW1403对给予州和地方政府资金和合作协议的统一行政要求UNIFORMADMINISTRATIVEREQUIREMENTSFORGRANTSANDCOOPERATIVEAGREEMENTSTOSTATEANDLOCALGOVERNMENTS1404政府范围的排除与暂停（非获得）GOVERNMENTWIDEDEBARMENTANDSUSPENSION(NONPROCUREMENT)1405对无毒品工作场所的政府范围的要求（财政援助）GOVERNMENTWIDEREQUIREMENTSFORDRUG-FREEWORKPLACE(FINANCIALASSISTANCE)