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美国试验用医疗器械的豁免制度(IDE)

试验用器械豁免是FD&C Act对于仅用于临床试验的医疗器械的管制措施，其主要的精神是让研究发展中的医疗器械可以免除掉对于以上市销售为目的的器械产品的种种管制，而以较简单的方式让制造商通过临床试验来收集安全性和有效性的信息资料，从而为510(k)和PMA申请提供数据支撑。FD&C Act 520(g)条款中授权FDA对临床试验用的器械，可以免除企业注册、产品登记、标示、510(k)、PMA或 医疗器械伤害报告等规定，除设计控制外，也不必遵循质量体系法规的要求，但仍要具有与上市时同样的合格标准（也就是说，制造商必须确保临床试验用的医疗器械已经符合安全性评估），遵守特别的标识规定（如注明限临床试验使用或警告语），制造商也不准对临床试验用的医疗器械有广告、商业化或任意延长临床试验期 限的行为。对于大多数的PMA申请而言，临床试验要求是必须的。然而，制造商在提交510(k)申请的时候，却仅在少数情况下要求提供临床试验数据。这里“试验”还包括对已合法上市器械的改进和新 用途的临床评价。

除豁免的情况外，所有试验用器械在其临床试验启动前都必须取得IDE许可。即：

• 通过审查 委员会（Institutional Review Board ，IRB）的审查，如果该器械属非危害性器械则可进行实施，如果属危害性器械，则除了IRB的批准之外，还须向FDA申请许可，申请者必须证明临床试验已 经妥善规划，充分保障受试者的权益，并完成风险评估；
• 对受试者的告知；
• 明确标识：仅作试验之用；
• 对研究过程实施监测；
• 进行记录和报告。

获得IDE许可意味着器械被允许合法运抵美国作临床试验之用。而且，制造商只有完成IDE程序的医疗器械临床试验报告，才能在510(k)或PMA审查中获得FDA的采纳认可。

医疗器械临床试验的实施必须遵循临床试验质量管理规范（Good Clinical Practices，GCP）。CFR中用于临床试验管制的法规主要包括：

• 21 CFR 812 试验用器械的豁免；
• 21 CFR 50  临床试验中人类受试者的保护；
• 21 CFR 56  人体试验医学伦理委员会；
• 21 CFR 54  临床试验机构财务信息的披露；
• 21 CFR 820 Subpart C 质量体系法规的设计控制。

FDA质量系统规则,21 CFR 820)

FDA临床研究者的财务披露,21 CFR 54)

FDA机构审查部,21 CFR 56)

FDA人类保护,21 CFR 50)

FDA研究设备免税,21 CFR 812)

您可以访问FDA网站获得详细信息：

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm

Device Advice: Investigational Device Exemption (IDE)

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.

Clinical evaluation of devices that have not been cleared for marketing requires:

• an IDE approved by an institutional review board (IRB). If the study involves a significant risk device, the IDE must also be approved by FDA;
• informed consent from all patients;
• labeling for investigational use only
• monitoring of the study and;
• required records and reports.

An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (Act) that would apply to devices in commercial distribution. Sponsors need not submit a PMA or Premarket Notification 510(k), register their establishment, or list the device while the device is under investigation. Sponsors of IDE's are also exempt from the Quality System (QS) Regulation except for the requirements for design control.

Good Clinical Practices (GCP)

Good Clinical Practices (GCP) refers to the regulations and requirements that must be complied with while conducting a clinical study. These regulations that apply to the manufacturers, sponsors, clinical investigators, institutional review boards, and the medical device. The primary regulations that govern the conduct of clinical studies are included in the Code of Federal Regulations, Title 21 (21 CFR):

• 21 CFR 812, Investigational Device Exemptions, covers the procedures for the conduct of clinical studies with medical devices including application, responsibilities of sponsors and investigators, labeling, records, and reports.
• 21 CFR 50, Protection of Human Subjects, provides the requirements and general elements of informed consent;
• 21 CFR 56, Institutional Review Boards, covers the procedures and responsibilities for institutional review boards (IRBs) that approve clinical investigations protocols;
• 21 CFR 54, Financial Disclosure by Clinical Investigators, covers the disclosure of financial compensation to clinical investigators which is part of FDA’s assessment of the reliability of the clinical data.
• 21 CFR 820 Subpart C, Design Controls of the Quality System Regulation, provides the requirement for procedures to control the design of the device in order to ensure that the specified design requirements are met.

Each of these regulations is discussed in detail throughout this section.

IRC编译整理

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