Committee For the Protection of Human Subjects

研究设备

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POLICY

When research is conducted to determine the safety and/or effectiveness of a medical device, the device must have an Investigational Device Exemption (IDE) issued by the FDA (21 CFR 812.2(a)), unless the device as used in the study meets the requirements for an abbreviated IDE (21 CFR 812.2(b)(1)) or meets the criteria for IDE exemption (21 CFR 812.2(c)).

关键术语：

医疗装置是指仪器，设备，实施，机器，发明，植入物，体外试剂或其他类似或相关的文章，包括旨在用于诊断疾病或其他疾病的组件部分或附件，或在治疗中，缓解，治疗或预防疾病或旨在影响身体的结构或任何功能，并且无法通过身体内部或身体上的化学作用实现其主要目的，并且不依赖于为成就而代谢其主要目的的目的。

Investigation意味着involvi临床调查或研究beplay苹果手机能用吗ng one or more subjects to determine the safety and/or effectiveness of a device.

研究装置means a device, including a transitional device, that is the object of an investigation.

重要的风险设备means an investigational device that:

• 旨在作为植入物，并为受试者的健康，安全或福利带来严重风险；
• Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
• 用于在诊断，治愈，缓解或治疗疾病或以其他方式防止人类健康损害方面使用重大重要性，并为受试者的健康，安全或福利带来严重风险；或者
• 否则，就有可能对受试者的健康，安全或福利造成严重风险。

赞助means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization.

Investigatormeans an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team.

赞助商评估器是指既有启动并实际进行单独或与他人进行调查的人，也就是在其直接指导下进行调查设备的管理，分配或使用的。该术语不包括个人以外的任何人。赞助商评估者的义务包括调查员和赞助商的义务。

意外的不良装置效果means any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

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程序：

Submission:

当研究评估医疗设备beplay苹果手机能用吗的安全性和/或有效性时，首席研究员（PI）将通过IRIS提交设备信息，包括但不限于：

1. FDA determination status/issuance letter
2. IDE编号
3. Rationale for IDE exemption, or rationale for Nonsignificant Risk (NSR) determination, as applicable
4. Product information document that lists device indications for use (i.e., “instructions for use,” “user manual,” “operating manual,” etc.).
5. 计划和分配研究设备

IRB staff will confirm that these items have been added to iRIS.

确认IDE编号：

If the PI has provided an IDE number, then the regulatory reviewer will confirm that the IDE number is valid by any of the following methods:

• For studies in which the UTHealth PI is not the sponsor-investigator (that is, there is an industry sponsor that holds the IDE, or the study is multi-site and an institution other than UTHealth is the lead site that initiated the study and holds the IDE), at least one of the following must be submitted to the IRB:
  • 赞助protocol documenting the IDE number.
  • 发起人记录IDE编号的书面通信。
  • Written communication from the FDA documenting the IDE number.
• 对于Uthealth PI是赞助商评估者（即Uthealth Pi拥有IDE）的研究，必须将以下一项提交给IRB：
  • If the protocol is submitted with an initial IDE application, written communication from the FDA documenting the IDE number.
  • 如果该协议已提交给现有的IDE，则FDA记录了FDA已批准提交给现有IDE的补品以添加新协议的补充。

审查IDE豁免：

If a study that assesses the safety and/or effectiveness of a medical device does not have an IDE, then the regulatory reviewer will evaluate whether the device as used in the study meets FDA IDE exemption criteria and will document the findings in iRIS under Reviewer Checklist and Comments. The regulatory reviewer may call on the expertise of IRB members for assistance in determining IDE exemption, for instance, in determining whether or not a device is used in accordance with the FDA approved indications. Additionally, CPHS may ask that the UTHealth PI request an IDE exemption determination from FDA.

The Study is IDE exempt if one of the below categories applies:

• The device is FDA-approved via PMA or FDA cleared via 510(k), and is being used or investigated in accordance with the indications in the FDA approved/cleared labeling
• A diagnostic device, if the sponsor complies with applicable requirements in 809.10(c) and if
  1. 测试是无创的；
  2. 不需要具有重大风险的侵入性抽样程序；
  3. Does not by design or intention introduce energy into a subject;and
  4. 不用另一种医学上建立的诊断产品或程序来确认诊断的情况下，不被用作诊断程序。
• 如果测试不是为了确定安全性或有效性，并且不会使受试者处于危险之中，则经过消费者偏好测试，修改测试或测试两个或多个设备的组合。
• A custom device as defined below, unless the device is being used to determine safety or effectiveness for commercial distribution. A custom device is one that:
  1. 一定会偏离通常可用的设备或适用的绩效标准或前市场批准要求，以遵守个人医师或牙医的顺序；
  2. 通常不可用其他医生或牙医使用或通常使用；
  3. 通常不以成品形式购买或在处方时分配；
  4. 不提供通过标签或广告进行商业发行；and
  5. 旨在由医师或牙医命名的个体患者使用，并应以特定形式为该患者制作，或者旨在满足专业实践过程中医生或牙医的特殊需求。
• 1976年5月28日之前，在商业分布中使用或调查了当时有效的标签指示，在1976年5月28日之前的商业分布中进行了商业分配。
• A device, other than a transitional device, introduced into commercial distribution on or after May 28, 1976, that FDA has determined to be substantially equivalent to a device in commercial distribution immediately before May 28, 1976, and that is used or investigated in accordance with the indications in the labeling FDA reviewed under subpart E of part 807 in determining substantial equivalence.

对于免于IDE法规的研究，IRB不需要决定该研究是否带来显着风险或无显着风险。但是，在调查开始之前，IRB仍必须根据IRB法规审查研究。beplay苹果手机能用吗涉及免于IDE要求的设备的研究建议可能有资格进行加急审查。

显着风险（SR）或非显着风险（NSR）设备决心：

FDA considers the significant risk (SR)/nonsignificant risk (NSR) determination to be part of the IRB’s responsibilities for conducting its initial review of a study, and unless FDA has already made a risk determination for the study, the IRB needs to make an SR/NSR determination. Sponsors or sponsor-investigators are responsible for making the initial SR/NSR determination and presenting it to the IRB. IRBs or sponsors may request a risk determination from FDA, and FDA will be the final arbiter.

如果Uthealth PI启动了这项研究，并且没有行业赞助商或其他领先地点，则监管审查员将促使IRB通过IRIS的评论进行审查清单和评论。IRB应通过在完整的董事会会议上审查相关信息来确定研究中使用的设备是SR还是NSR。该信息包括对设备的描述，设备进行的先前调查报告，拟议的研究计划，主题选择标准以及SR或NSR确定的PI的理由。IRB审稿人应考虑对受试者的健康，安全或福利造成严重风险的潜力，并根据调查中的设备使用拟议使用设备的风险确定，而不是仅在设备中。IRB还可以要求Uthealth PI要求从FDA确定SR/NSR。

当IRB确定研究是SR时，IRB将要求PI向FDA提交IDE申请。IRB可能会推迟或批准待处理，但是IRB工作人员不会发出批准信，直到PI提供了FDA批准或有条件批准信或FDA的书面通信的副本，该副本声明该设备是NSR。SR设备研究必须遵循21 CFR 812的所有IDE法规，并且必须在FDA进行之前批准IDE申请。NSR设备研究必须遵循21 CFR 812.2（b）的缩写要求，包括对设备标签，IRB批准，知情同意，监控，记录，报告和禁止晋升的要求；但是，IDE应用不必提交给FDA进行NSR设备研究。

IRB工作人员将在会议记录中记录SR或NSR的确定。会议记录应描述IRB的SR或NSR确定的原因，还可能包括用于建立研究IDE状态的文档。对于SR确定，此类文档可以包括例如IDE批准或FDA的有条件批准信的副本。对于NSR确定，该文档可以包括FDA的NSR确定。

SR/NSRD当Uthealth Pi不是赞助商评估器时，可怕:如果UTHealthπsponsor-investigat或者[that is, there is an industry sponsor that serves as the IDE sponsor, or the study is multi-site and an institution other than UTHealth is the lead site that serves as the IDE sponsor], then the lead IRB overseeing the IDE sponsor will make an SR/NSR determination for the study as a whole; however, UTHealth CPHS shall review the SR/NSR determination made by the lead IRB and must agree with the determination before approving the study locally at UTHealth. If FDA has determined SR or NSR, then FDA is the final arbiter, and CPHS will move forward with FDA’s determination.

IRB测定NSR后SR的FDA测定：如果F​​DA确定在赞助商和负责任的IRB确定该设备为NSR之后，研究设备为SR，则CPHS将遵循FDA的指导，是继续进行研究的指导。

审查研究设备的存储和分配计划：

CPHS应确保PI控制研究设备的计划是适当的。通常，药房服务应用于存储和分配研究设备。CPHS可能会批准在某些情况下，有经验的研究者或研究协调员的计划，例如通过行业赞助的研究，并提供监测计划。beplay苹果手机能用吗

申请法规和指导

1. Investigational Device Exemptions
2. FDA IDE指南 - IRB，临床研究人员和赞助商的信息表指南 - 明显的风险和非显着风险医疗设备研究
3. FDA IDE Guidance - Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors – Frequently Asked Questions About Medical Devices

REFERENCES TO OTHER SOP

1. Initial Review
2. Regulatory Review

ATTACHMENTS

1. 医疗装置Panel - CPHS Application Form

If you find errors in this document, contactclinicals@uth.tmc.edu

文件编号：	101-D02
Document Name:	研究设备
审核者：	Executive Director, Research Compliance
有效的：	2008年8月1日
Revision History:	1 Jan 2009, 1 Aug 2011, 1 Jun 2016, 19 Jan 2018, 1 Jun 2021

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