PART812—INVESTIGATIONAL
DEVICE EXEMPTIONS
调查的机械豁免
Subpart A—General Provisions
Sec.
812.1Scope.范围
812.2Applicability.申请
812.3Definitions.定义
812.5Labeling of investigational devices.标记调查用的机械
812.7Prohibition of promotion and other practices.推广的禁用和实行812.10Waivers.豁免
812.18Import and export requirements.进口和出口的需求。
812.19Address for IDE correspondence.IDE对应的定位
Subpart B—Application and Administrative Action部分B-申请程序和行政诉讼
812.20Application.申请，申請內容
812.25Investigational plan.研究计划
812.27Report of prior investigations.前调查报告(临床前报告)
812.30FDA action on applications.FDA的申请程序上的行动
812.35Supplemental applications.补充申请
812.36Treatment u of an investigational device.研究机械的处方
812.38Confidentiality of data and information.数据和信息的保密性。
Subpart C—Responsibilities of Sponsors对厂商的责任分部C
812.40General responsibilities of sponsors.厂商的一般责任
812.42FDA and IRB approval.FDA和IRB的批准
812.43Selecting investigators and monitors.选择的调查和监控。
812.45Informing investigators.告知调查。
812.46Monitoring investigations.监测调查。
812.47Emergency rearch under§50.24of this chapter.紧急研究
Subpart D—IRB Review and Approval分部D-IRB的审查和批准
812.60IRB composition,duties,and functions.IRB组成，职责和功能
812.62IRB approval.IRB的批准。
812.64IRB’s continuing review.IRB的持续检讨
812.65[Rerved][修改中]
812.66Significant risk device determinations.重大危险设备的确定
Subpart E—Responsibilities of Investigators研究者的责任
812.100General responsibilities of investigators.研究者的一般责任
812.110Specific responsibilities of investigators.研究者的特殊责任
812.119Disqualification of a clinical investigator.被取消资格的临床研究者
§812.1Scope.
(a)The purpo of this part is to encourage,to the extent consistent with the
protection of public health and safety and with ethical standards,the discovery and development of uful devices intended for human u,and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpo.
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)This part provides procedures for the conduct of clinical investigations of
devices.An approved investigational device exemption(IDE)permits a device that otherwi would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpo of conducting investigations of that device.An IDE approved under§812.30or considered approved under§812.2(b)exempts a device from the requirements of the following ctions of the Federal Food,Drug,and Cosmetic Act(the act)and regulations issued thereunder:Misbranding under ction502of the act, registration,listing,and premarket notification under ction510, performance standards under ction514,premarket approval under ction515,
a banned device regulation under ction516,records and reports under ction
519,restricted device requirements under ction520(e),good manufacturing practice requirements under ction520(f)except for the requirements found in§820.30,if applicable(unless the sponsor states comply with the requirements under§812.20(b)(3)or§812.140(b)(4)(v))and color additive requirements under ction721.(b)References in this part to regulatory ctions of the Code of Federal Regulations are to chapter I of title 21,unless otherwi noted.[45FR3751,Jan.18,1980,as amended at59FR14366, 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.This part applies to all clinical investigations of devices to determine safety and effectiveness,except as provided in paragraph(c)of this ction.
(b)Abbreviated requirements.The following categories of investigations are considered to have approved applications for IDE’s,unless FDA has notified a sponsor under§812.20(a)that approval of an application is required:
（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)Complies with the requirements of§812.46with respect to monitoring investigations;
(v)Maintains the records required under§812.140(b)(4)and(5)and makes the reports required under§812.150(b)(1)through(3)and(5)through(10);
(vi)Ensures that participating investigators maintain the records required by§812.140(a)(3)(i)and make the reports required under§812.150(a)(1),(2),(5), and(7);and
(vii)Complies with the prohibitions in§812.7against promotion and other practices.
(2)An investigation of a device other than one subject to paragraph(e)of this
ction,if the investigation was begun on or before July16,1980,and to be completed,and is completed,on or before January19,1981.
(c)Exempted investigations.
This part,with the exception of§812.119,does not apply to investigations of the
following
categories of devices:
(1)A device,other than a transitional device,in commercial distribution immediately before May28,1976,when ud or investigated in accordance with the indications in labeling in effect at that time.
(2)A device,other than a transitional device,introduced into commercial distribution on or after May28,1976,that FDA has determined to be substantially equivalent to a device in
commercial distribution immediately before May28,1976,and that is ud or investigated in accordance with the indications in the labeling FDA reviewed under subpart E of part807in determining substantial equivalence.
§812.119例外，这部分并不适用于以下调查
的设备的类别：
1.一个仪器，一个过渡性的装置以外，在商业分销紧接之前5月28日，1976年，使用时根据当时的效果上的指示标签或调查。
2.设备，其他比一个过渡性的设备，引入商业流通于1976年5月28日或之后，FDA已经确定设备大致相当于商业分销，立即在1976年5月28日之前，那就是使用或调查审查按照在标签FDA的迹象，下部分807在确定实质等同性条E款。
(3)A diagnostic device,if the sponsor complies with applicable requirements in §809.10(c)and if the testing:
(i)Is noninvasive,
(ii)Does not require an invasive sampling procedure that prents significant risk, (iii)Does not by design or intention introduce energy into a subject,and (iv)Is not ud as a diagnostic procedure without confirmation of the diagnosis by another,medically established diagnostic product or procedure.
(4)A device undergoing consumer preference testing,testing of a modification,or
testing of a combination of two or more devices in commercial distribution,if the testing is not for the purpo of determining safety or effectiveness and does not put subjects at risk.
(5)A device intended solely for veterinary u.
(6)A device shipped solely for rearch on or with laboratory animals and labeled
in accordance with§812.5(c).
(7)A custom device as defined in§812.3(b),unless the device is being ud to
determine safety or effectiveness for commercial distribution.
的诊断设备，如果申请商符合适用§809.10（c）和测试要求：
1.非侵入性，
2.并无需要侵入性的抽样程序，呈现显著的风险，
3.不设计或意图引进能源成主题，
4.不使用作为一个诊断过程没有诊断确认，另一位医学诊断产品或程序。
4.的移动设备接受消费者的喜好的测试，测试的变形，或在商业销售中的两个或多个设备的组合的测试，如果测试是不是为目的确定安全性或有效性，不把风险科目。
5.设备仅供兽医使用
6.设备运仅用于研究或实验动物，并按照§812.5（三）标记。
7.§812.3（b）条所界定的定制设备，除非设备被用来确定商业流通的安全性或有效性。
(d)Limit on certain exemptions.
In the ca of class II or class III device described in paragraph(c)(1)or(2) of this ction,this part applies beginning on the date stipulated in an FDA regulation or order that calls for the submission of premarket approval applications for an unapproved class III device,or establishes a performance standard for a class II device.
（四）某些豁免的限制。
本节段所描述的II类或III类设备（三）（1）或（2）的情况下，本部分适用之日起，FDA法规或命令，要求提交的上市前批准申请规定未经批准的第三类设备，或建立一个II类设备的性能标准。
(e)Investigations subject to IND’s.A
sponsor that,on July16,1980,has an effective investigational new drug application (IND)for an investigation of a device shall continue to comply with the requirements of part312until90days after t
hat date.To continue the investigation after that date,a sponsor shall comply with paragraph(b)(1)of this ction,if the device is not a significant risk device,or shall have obtained FDA approval under§812.30 of an IDE application for the investigation of the device.
（五）新药申请的受试者
赞助商，1980年7月16日，有一个有效的研究新药申请（IND）的设备进行调查，直到该日期后90日内，将继续遵守与312部分的要求。要继续调查，在该日期之后，赞助商应符合本节（b）段（1），如果该设备不是一个显著风险装置，或已获得美国食品和药物管理局的批准，根据§812.30IDE申请调查设备。
§812.3Definitions.
(a)Act means the Federal Food,Drug,and Cosmetic Act(ctions201–
901,52Stat.1040et q.,as amended(21U.S.C.301–392)).
(b)Custom device means a device that:
(1)Necessarily deviates from devices generally available or from an applicable performance standar
d or premarket approval requirement in order to comply with the order of an individual physician or dentist;
