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PART812—INVESTIGATIONALDEVICEEXEMPTIONS调查的机械豁免SubpartA—GeneralProvisionsSec.812.1Scope.范围812.2Applicability.申请812.3Definitions.定义812.5Labelingofinvestigationaldevices.标记调查用的机械812.7Prohibitionofpromotionandotherpractices.推广的禁用和实行812.10Waivers.豁免812.18Importandexportrequirements.进口和出口的需求。812.19AddressforIDEcorrespondence.IDE对应的定位SubpartB—ApplicationandAdministrativeAction部分B-申请程序和行政诉讼812.20Application.申请,申請內容812.25Investigationalplan.研究计划812.27Reportofpriorinvestigations.前调查报告(临床前报告)812.30FDAactiononapplications.FDA的申请程序上的行动812.35Supplementalapplications.补充申请812.36Treatmentuseofaninvestigationaldevice.研究机械的处方812.38Confidentialityofdataandinformation.数据和信息的保密性。SubpartC—ResponsibilitiesofSponsors对厂商的责任分部C812.40Generalresponsibilitiesofsponsors.厂商的一般责任812.42FDAandIRBapproval.FDA和IRB的批准812.43Selectinginvestigatorsandmonitors.选择的调查和监控。812.45Informinginvestigators.告知调查。812.46Monitoringinvestigations.监测调查。812.47Emergencyresearchunder§50.24ofthischapter.紧急研究SubpartD—IRBReviewandApproval分部D-IRB的审查和批准812.60IRBcomposition,duties,andfunctions.IRB组成，职责和功能812.62IRBapproval.IRB的批准。812.64IRB’scontinuingreview.IRB的持续检讨812.65[Reserved][修改中]812.66Significantriskdevicedeterminations.重大危险设备的确定SubpartE—ResponsibilitiesofInvestigators研究者的责任812.100Generalresponsibilitiesofinvestigators.研究者的一般责任812.110Specificresponsibilitiesofinvestigators.研究者的特殊责任812.119Disqualificationofaclinicalinvestigator.被取消资格的临床研究者§812.1Scope.(a)Thepurposeofthispartistoencourage,totheextentconsistentwiththeprotectionofpublichealthandsafetyandwithethicalstandards,thediscoveryanddevelopmentofusefuldevicesintendedforhumanuse,andtothatendtomaintainoptimumfreedomforscientificinvestigatorsintheirpursuitofthispurpose.一）这部分的目的是要鼓励，保护公众健康和安全，道德标准，发现和开发有用的设备用于人类使用的相一致的程度，并为此目的，以保持最佳的自由科学的研究人员在他们的追求自己的目标。(b)Thispartprovidesproceduresfortheconductofclinicalinvestigationsofdevices.Anapprovedinvestigationaldeviceexemption(IDE)permitsadevicethatotherwisewouldberequiredtocomplywithaperformancestandardortohavepremarketapprovaltobeshippedlawfullyforthepurposeofconductinginvestigationsofthatdevice.AnIDEapprovedunder§812.30orconsideredapprovedunder§812.2(b)exemptsadevicefromtherequirementsofthefollowingsectionsoftheFederalFood,Drug,andCosmeticAct(theact)andregulationsissuedthereunder:Misbrandingundersection502oftheact,registration,listing,andpremarketnotificationundersection510,performancestandardsundersection514,premarketapprovalundersection515,abanneddeviceregulationundersection516,recordsandreportsundersection519,restricteddevicerequirementsundersection520(e),goodmanufacturingpracticerequirementsundersection520(f)exceptfortherequirementsfoundin§820.30,ifapplicable(unlessthesponsorstatesanintention.tocomplywiththeserequirementsunder§812.20(b)(3)or§812.140(b)(4)(v))andcoloradditiverequirementsundersection721.(b)ReferencesinthisparttoregulatorysectionsoftheCodeofFederalRegulationsaretochapterIoftitle21,unlessotherwisenoted.[45FR3751,Jan.18,1980,asamendedat59FR14366,Mar.28,1994;61FR52654,Oct.7,1996]（b）本部分提供设备的临床调查程序的行为。经批准的调查装置豁免（IDE）允许的设备，否则将须遵守的绩效标准，或有运合法进行调查的目的，该设备的上市前批准。根据§812.30批准的IDE或审议批准，根据§812.2（b）豁免的设备“联邦食品，药品和化妆品法”（该法）和法规据此颁布的以下部分的要求：根据第502Misbranding的行为，登记，上市，上市前通知，根据第510条，第514的性能标准下，根据第515上市前批准，禁止器械监管，记录和报告根据第519，限制设备的需求，根据第520（E）根据第516，良好生产规范要求，根据第520（f）除§820.30中的要求，如果适用（除非赞助商规定的intention.to符合这些要求根据§812.20（B）（3）或§812.140（B）（4）（V））和第721条的颜色添加剂规定。（二）在这部分的监管部分的联邦法规法典第21章我，除非另有说明。§812.2Applicability.(a)General.Thispartappliestoallclinicalinvestigationsofdevicestodeterminesafetyandeffectiveness,exceptasprovidedinparagraph(c)ofthissection.(b)Abbreviatedrequirements.ThefollowingcategoriesofinvestigationsareconsideredtohaveapprovedapplicationsforIDE’s,unlessFDAhasnotifiedasponsorunder§812.20(a)thatapprovalofanapplicationisrequired:（a）一般。本部分适用于所有设备的临床调查，以确定安全性和有效性，在本节（c）段规定的除外。（二）缩写的要求。以下类别的调查被认为是IDE的已批准的申请程序，除非FDA已通知申请商根据§812.20（a）在批准申请要求：1）调查的其他设备比重大的风险的移动设备，如果该设备是不是一个被禁止的设备和赞助商：（一）按照标签设备§812.5;（二）调查获得IRB的批准后提出审查IRB简要说明所以，该设备是不是一个显著的风险设备，并能保持这样的批准;（三）确保每个调查参与调查设备获取从每个主题下研究者的关怀下，知情同意根据第50部分和文件，除非文档免除其IRB根据§56.109（C）。（四）符合要求(iv)Complieswiththerequirementsof§812.46withrespecttomonitoringinvestigations;(v)Maintainstherecordsrequiredunder§812.140(b)(4)and(5)andmakesthereportsrequiredunder§812.150(b)(1)through(3)and(5)through(10);(vi)Ensuresthatparticipatinginvestigatorsmaintaintherecordsrequiredby§812.140(a)(3)(i)andmakethereportsrequiredunder§812.150(a)(1),(2),(5),and(7);and(vii)Complieswiththeprohibitionsin§812.7againstpromotionandotherpractices.(2)Aninvestigationofadeviceotherthanonesubjecttoparagraph(e)ofthissection,iftheinvestigationwasbegunonorbeforeJuly16,1980,andtobecompleted,andiscompleted,onorbeforeJanuary19,1981.(c)Exemptedinvestigations.Thispart,withtheexceptionof§812.119,doesnotapplytoinvestigationsofthefollowingcategoriesofdevices:(1)Adevice,otherthanatransitionaldevice,incommercialdistributionimmediatelybeforeMay28,1976,whenusedorinvestigatedinaccordancewiththeindicationsinlabelingineffectatthattime.(2)Adevice,otherthanatransitionaldevice,introducedintocommerciald