Humanitarian Use Device (HUD)
POLICY
Approval by IRB must be obtained prior to clinical use of a Humanitarian Use Device (HUD) at UTHealth. A request to use an HUD shall be reviewed and approved at a full board IRB meeting; however, subsequent continuing review may be conducted by expedited procedures, unless the IRB determines that full board review should be performed.
Key Terms
人道主义使用设备（HUD）is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year.
AHumanitarian Device Exemption (HDE)is an application for FDA approval to market a device as an HUD. An FDA-approved HDE authorizes the HDE applicant to market the HUD in accordance with approved labeling and indication(s) for use, and healthcare providers may use the device clinically to treat or diagnose patients. FDA approves an HDE on the condition that the device will not expose patients to an unreasonable or significant risk of illness or injury, and the probable benefit to health from use of the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment; the device would not be available to a person with the disease or condition in question without the HDE, and no comparable device, other than another device approved under an HDE or Investigational Device Exemption (IDE), is available to treat or diagnose the disease or condition; and the device is designed to treat or diagnose a disease or condition that affects not more than 8,000 individuals in the United States per year.
通过HDE批准的HUD与通过预批准（PMA）批准的设备之间的关键差异：An HUD approved by HDE is exempt from the requirement of establishing a reasonable assurance of effectiveness, which is required for PMA approval; use of HUDs in clinical care of patients at a facility must receive prior approval from either an IRB or an appropriate local committee, which is not required for PMA-approved devices; and for HUDs, medical device reports (MDRs) should be submitted to the IRB of record or appropriate local committee (in addition to submitting MDRs to FDA, as for PMA-approved devices).
Clinical Investigationmeans research involving one or more subjects to determine the safety and/or effectiveness of a device.
重伤means an injury or illness that is life-threatening, results in permanent impairment of a body function or permanent damage to a body structure, or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
PROCEDURE
Submission for Clinical Use of an HUD：医师将通过IRIS提交CPHS申请，以及：
- A letter from the sponsor which contains the following information:
- 设备的通用和商品名
- The FDA HDE number
- HUD指定日期
- 使用设备的指示
- A description of the device
- 使用该设备的禁忌症，警告和预防措施
- 设备对健康的不利影响
- Alternative practices and procedures
- 营销历史
- A summary of studies using the device
- 产品标签
- 可能伴随HUD的患者信息包
- A sample consent form for the use of the HUD in clinical care, if required by the IRB
- 医师建议如何使用该设备的摘要，包括对任何筛查程序的描述，HUD程序以及任何患者的随访，测试或程序
对临床使用的住房和城市发展部:IRB将在召集的IRB会议上审查HUD临床使用的提交。在审查HUD在临床护理中的使用时，IRB应该认识到FDA已经确定健康的可能收益大于仅在其批准的指示内使用HUD的可能风险。
The IRB will verify that the documents provided are consistent with the manufacturing labeling and the approved use under the HDE. The IRB will follow the review criteria in 21 CFR 56.111 and elsewhere in part 56, where applicable. The IRB will review the risks to patients that are found in the HDE-approved product labeling, ensure the risks are minimized, and evaluate whether the risks are reasonable in relation to the proposed use of the device at UTHealth. When the IRB is reviewing a request for clinical use of an HUD at UTHealth, it does not make a Significant Risk (SR)/Nonsignificant Risk (NSR) determination because use of a legally marketed HUD to treat or diagnose patients is not a clinical investigation of a device that falls under 21 CFR 812.
IRB可以使用其酌处权来确定如何批准使用HUD，包括通过培训和专业知识来考虑专业人士的资格来使用该设备。IRB可以根据疾病进展的一种或多种措施，事先使用和失败的任何替代治疗方式，报告要求，适当的后续预防措施和评估或其他标准，委员会决定是基于疾病进展，事先使用和失败的限制，委员会决定是合适的。
Duration of Approval:IRB可以批准使用HUD一年或更短的时间使用HUD。IRB可以在Uthealth的HUD临床使用中获得广泛的批准，前提是HUD的使用在广义批准的条款范围内。在某些情况下，IRB可能需要审查和批准对HUD的个人用途。IRB可以批准使用HUD的使用，例如，在协议下或逐案基础上没有任何进一步的限制。
知情同意：IRB通常需要预期的知情同意，以临床使用HUD。如果有的话，将包含信息的患者信息包为帮助患者做出有关在临床护理中使用HUD的明智决定的明智决定，则应包括以下信息（如果适用）：
- A statement that the device is a HUD and effectiveness for the labeled indication has not been demonstrated.
- HUD旨在诊断或治疗HDE标签中描述的疾病或状况的解释，并且没有可比较的装置可用于治疗疾病或病情。
- 描述与使用HUD相关的任何辅助程序，对HUD使用的描述以及所有已知的风险或不适。
- An explanation of the postulated mechanism of action of the HUD in relation to the disease or condition.
设备标签必须包括以下陈述：“人道主义设备。由联邦法律授权用于[指定疾病或病情]的[治疗或诊断]。该设备在此用途的有效性尚未得到证明。”
继续审查HUD的临床使用：The IRB that performed initial review of a request to use an HUD clinically must perform continuing review of the HUD use. The IRB may use expedited procedures for continuing review, similar to procedures described in the policy on Expedited Review. At continuing review, the IRB will consider the risk and benefit information available and any medical device reports (MDRs). The IRB may ask the HDE holder for copies of the safety information submitted to FDA in required periodic reports, and in this way, information that could have a bearing on human safety would be considered at the time of continuing review.
Use of an HUD outside of Approved Indication:If a physician wants to use an HUD clinically outside its approved indication(s), the IRB will determine the extent of oversight. The IRB may require that the physician obtain informed consent from the patient and may require additional reasonable patient protection measures are followed, such as devising schedules to monitor the patient, taking into consideration the patient’s specific needs and the limited information available about the risks and probable benefits of the device.
Reporting for Clinical Use of an HUD:每当医师收到或以其他方式意识到信息时，从任何消息来源都合理地表明，HUD已或可能导致或可能导致或导致患者的死亡或严重伤害，医生必须向FDA和IRB报告此类发现尽快，但根据报告意外问题的政策和程序，医生首次了解效果或问题后的10个工作日不晚。此报告是根据21 CFR 803.30的规定，而不是替代FDA和/或制造商报告要求的补充。医师或医疗保健提供者必须迅速向IRB报告有关HUD的任何FDA诉讼。对HUD或HUD的临床使用的修改应根据变更请求和协议修正案的政策和程序立即报告给IRB。
紧急临床使用HUD：In an emergency situation, an HUD may be used clinically to prevent serious harm or death of a patient; however, in this situation, the physician and HDE holder must follow the same emergency use procedures described in policy and Individual Patient Expanded Access – Investigational Device. Briefly, in such an emergency situation, the physician shall contact the IRB office with information on the emergency use. The IRB office, after consultation with an IRB Chair, will provide a letter of concurrence for emergency clinical use of the HUD. FDA recommends that the physician submit a follow-up report on the patient’s condition to the HDE holder.
HUD的研究用途：An HUD used in a clinical investigation is subject to the same requirements that apply to all FDA-regulated clinical studies and must be performed under IRB oversight as described in the policy Investigational Devices. Further, if the HUD is being studied for a use other than its approved indication (i.e., off label), then an IDE may be required. If FDA has not already made an SR/NSR determination, then at the initial review the IRB must make an SR/NSR determination for the HUD as used in the study. If SR is determined, then the entity or PI that initiated the study must submit an IDE application to FDA, and the IDE must be approved by FDA before the investigation may begin.
APPLICABLE REGULATIONS AND GUIDANCE
- 21 CFR 814 Part H: Humanitarian Use Devices
- FDA Guidance - Humanitarian Device Exemption (HDE) Program
REFERENCE TO OTHER POLICIES
- 意外的问题，涉及对象或其他人的风险
- Change Requests and Amendments
- Emergency Use of Investigational Drug or Device
- Investigational Devices
ATTACHMENTS
- 初始审查面板 - 人道主义使用设备
If you find errors in this document, contactclinicals@uth.tmc.edu
文件号码： |
101-D03 |
Document Name: |
Humanitarian Use Device |
审核者： |
Executive Director, Research Compliance |
有效的： |
2008年8月1日 |
Revision History: |
2011年8月1日，2016年6月1日，2019年1月21日，2021年6月1日 |
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UTHealth’s Compliance Hotline (1-888-472-9868)
Committee for the Protection of Human Subjects IRIS Support713-500-7960 |
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