美國(guó)試驗(yàn)用醫(yī)療器械的豁免制度(IDE)

美國(guó)試驗(yàn)用醫(yī)療器械的豁免制度(IDE)



試驗(yàn)用器械豁免是FD&C Act對(duì)于僅用于臨床試驗(yàn)的醫(yī)療器械的管制措施，其主要的精神是讓研究發(fā)展中的醫(yī)療器械可以免除掉對(duì)于以上市銷(xiāo)售為目的的器械產(chǎn)品的種種管制，而以較簡(jiǎn)單的方式讓制造商通過(guò)臨床試驗(yàn)來(lái)收集安全性和有效性的信息資料,，從而為510(k)和PMA申請(qǐng)?zhí)峁?shù)據(jù)支撐,。FD&C Act 520(g)條款中授權(quán)FDA對(duì)臨床試驗(yàn)用的器械，可以免除企業(yè)注冊(cè),、產(chǎn)品登記,、標(biāo)示、510(k),、PMA或醫(yī)療器械傷害報(bào)告等規(guī)定,，除設(shè)計(jì)控制外，也不必遵循質(zhì)量體系法規(guī)的要求,，但仍要具有與上市時(shí)同樣的合格標(biāo)準(zhǔn)（也就是說(shuō),，制造商必須確保臨床試驗(yàn)用的醫(yī)療器械已經(jīng)符合安全性評(píng)估），遵守特別的標(biāo)識(shí)規(guī)定（如注明限臨床試驗(yàn)使用或警告語(yǔ)）,，制造商也不準(zhǔn)對(duì)臨床試驗(yàn)用的醫(yī)療器械有廣告,、商業(yè)化或任意延長(zhǎng)臨床試驗(yàn)期限的行為。對(duì)于大多數(shù)的PMA申請(qǐng)而言,，臨床試驗(yàn)要求是必須的,。然而，制造商在提交510(k)申請(qǐng)的時(shí)候,，卻僅在少數(shù)情況下要求提供臨床試驗(yàn)數(shù)據(jù),。這里“試驗(yàn)”還包括對(duì)已合法上市器械的改進(jìn)和新 用途的臨床評(píng)價(jià)。

   

除豁免的情況外,，所有試驗(yàn)用器械在其臨床試驗(yàn)啟動(dòng)前都必須取得IDE許可,。即：

    * 通過(guò)審查 委員會(huì)（Institutional Review Board ，IRB）的審查,，如果該器械屬非危害性器械則可進(jìn)行實(shí)施,，如果屬危害性器械，則除了IRB的批準(zhǔn)之外,，還須向FDA申請(qǐng)?jiān)S可,，申請(qǐng)者必須證明臨床試驗(yàn)已 經(jīng)妥善規(guī)劃，充分保障受試者的權(quán)益,，并完成風(fēng)險(xiǎn)評(píng)估,；
    * 對(duì)受試者的告知；
    * 明確標(biāo)識(shí)：僅作試驗(yàn)之用,；
    * 對(duì)研究過(guò)程實(shí)施監(jiān)測(cè),；
    * 進(jìn)行記錄和報(bào)告。



獲得IDE許可意味著器械被允許合法運(yùn)抵美國(guó)作臨床試驗(yàn)之用,。而且，制造商只有完成IDE程序的醫(yī)療器械臨床試驗(yàn)報(bào)告，才能在510(k)或PMA審查中獲得FDA的采納認(rèn)可,。

   

醫(yī)療器械臨床試驗(yàn)的實(shí)施必須遵循臨床試驗(yàn)質(zhì)量管理規(guī)范（Good Clinical Practices,，GCP）。CFR中用于臨床試驗(yàn)管制的法規(guī)主要包括：

    * 21 CFR 812 試驗(yàn)用器械的豁免,；
    * 21 CFR 50  臨床試驗(yàn)中人類(lèi)受試者的保護(hù),；
    * 21 CFR 56  人體試驗(yàn)醫(yī)學(xué)倫理委員會(huì)；
    * 21 CFR 54  臨床試驗(yàn)機(jī)構(gòu)財(cái)務(wù)信息的披露,；
    * 21 CFR 820 Subpart C 質(zhì)量體系法規(guī)的設(shè)計(jì)控制,。



FDA質(zhì)量系統(tǒng)規(guī)則,21 CFR 820)



FDA臨床研究者的財(cái)務(wù)披露,21 CFR 54)



FDA機(jī)構(gòu)審查部,21 CFR 56)



FDA人類(lèi)保護(hù),21 CFR 50)



FDA研究設(shè)備免稅,21 CFR 812)



您可以訪問(wèn)FDA網(wǎng)站獲得詳細(xì)信息：

[url]http://www./MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm[/url]



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.