上市前批准
概述
Premarket approval (PMA) is the FDA processof scientific and regulatory review to evaluate the safety and effectiveness ofClass III medical devices. Class III devices are those that support or sustainhuman life, are of substantial importance in preventing impairment of humanhealth, or which present a potential, unreasonable risk of illness or injury.Due to the level of risk associated with Class III devices, FDA has determinedthat general and special controls alone are insufficient to assure the safetyand effectiveness of class III devices. Therefore, these devices require apremarket approval (PMA) application under section 515 of the FD&C Act inorder to obtain marketing clearance. Please note that some Class IIIpreamendment devices may require a Class III 510(k).
上市前批准（PMA）是FDA对科学和法规审查过程，以评估III类医疗器械的安全性和有效性。III类器械是支持或维持人类生命的装置，对于预防人体健康的损害具有重要意义，或有潜在的，不合理的疾病或伤害风险。由于与III类器械相关的风险程度，FDA已经确定，通用和特殊控制措施不足以确保III类器械的安全性和有效性。因此，这些器械需要根据FD＆C法案第515节进行上市前批准（PMA）申请，以获得营销许可。请注意，一些III类预保护器械可能需要III类510（k）。
PMA is the most stringent type of devicemarketing application required by FDA. The applicant must receive FDA approvalof its PMA application prior to marketing the device. PMA approval is based ona determination by FDA that the PMA contains sufficient valid scientificevidence to assure that the device is safe and effective for its intendeduse(s). An approved PMA is, in effect, a private license granting the applicant(or owner) permission to market the device. The PMA owner, however, canauthorize use of its data by another.
PMA是FDA要求的最严格的器械营销申请。在营销器械前，申请人必须获得其PMA申请的FDA批准。PMA批准是基于FDA的决定，PMA包含足够的有效科学证据，以确保该设备对其预期用途是安全有效的。批准的PMA实际上是授予申请人（或所有者）允许营销器械的私人许可。然而，PMA所有者可以授权其他用户使用其数据。
The PMA applicant is usually the person whoowns the rights, or otherwise has authorized access, to the data and otherinformation to be submitted in support of FDA approval. This person may be anindividual, partnership, corporation, association, scientific or academicestablishment, government agency or organizational unit, or other legal entity.The applicant is often the inventor/developer and ultimately the manufacturer.
PMA申请人通常是拥有向FDA批准提交的数据和其他信息的权利或以其他方式授权访问权限的人。这个人可能是个人，合伙，法人，协会，科学或学术机构，政府机构或组织单位，或其他法律实体。申请人通常是发明人/开发商，最终制造商。
FDA regulations provide 180 days to reviewthe PMA and make a determination. In reality, the review time is normallylonger. Before approving or denying a PMA, the appropriate FDA advisorycommittee may review the PMA at a public meeting and provide FDA with thecommittee's recommendation on whether FDA should approve the submission. AfterFDA notifies the applicant that the PMA has been approved or denied, a noticeis published on the Internet (1) announcing the data on which the decision isbased, and (2) providing interested persons an opportunity to petition FDAwithin 30 days for reconsideration of the decision.
FDA规定提供180天审查PMA并做出决定。实际上，审查时间通常较长。在批准或否认PMA之前，FDA咨询委员会可以在公开会议上适当审查PMA，并向FDA提交是否批准提交的建议。FDA通知申请人已经批准或拒绝了PMA后，在互联网上发布通知（1）宣布作出决定的数据，（2）向有兴趣的人提供30天内向FDA提出申请的机会重新考虑决定。
The regulation governing premarket approvalis located in Title 21 Code of Federal Regulations (CFR) Part 814, Premarket Approval. Aclass III device that fails to meet PMA requirements is considered to beadulterated under section 501(f) of the FD&C Act and cannot be marketed.
管理上市前批准的条例位于“联邦法规”第21卷（CFR）第814部分，上市前批准。根据FD＆C法案501（f）条，不符合PMA要求的三类器械被认为是掺假的，不能上市。
什么时候需要PMA
PMA requirements apply to Class III devices,the most stringent regulatory category for medical devices. Device productclassifications can be found by searching the Product Classification Database.The database search provides the name of the device, classification, and a linkto the Code of Federal Regulations (CFR), if any. The CFR provides the devicetype name, identification of the device, and classification information.
PMA要求适用于医疗器械最严格的监管类别III类器械。通过搜索产品分类数据库可以找到器械产品分类。数据库搜索提供器械的名称，分类以及指向“联邦法规”（CFR）的链接，如果有的话。CFR提供器械类型名称，器械标识和分类信息。
A regulation number for Class III devicesmarketed prior to the 1976 Medical Device Amendments is provided in the CFR.The CFR for these Class III devices that require a PMA states that the deviceis Class III and will provide an effective date of the requirement for PMA. Ifthe regulation in the CFR states that “No effective date has been establishedof the requirement for premarket approval,” a Class III 510(k) should besubmitted.
III类器械的规定号由CFR在1976年之前“医疗器械修订”中提供。这些III类器械的CFR要求PMA声明该器械是III类，并提供PMA要求的有效日期。如果CFR的规定“没有确定上市前批准要求的生效日期”，则应提交第III类510（k）。
Please note that PMA devices often involvenew concepts and many are not of a type marketed prior to the Medical Device Amendments.Therefore, they do not have a classification regulation in the CFR. In thiscase, the product classification database will only cite the device type nameand product code.
请注意，PMA器械通常涉及新概念，许多在医疗器械修订之前并不是市场上的类型。因此，它们在CFR中没有分类规定。在这种情况下，产品分类数据库将仅引用器械类型名称和产品代码。
If it is unclear whether the unclassifieddevice requires a PMA, use the three letter product code to search thePremarket Approval (PMA) database andthe 510(k) Premarket Notification database. Thesedatabases can also be found by clicking on the hypertext links at the top ofthe product classification database web page. Enter only the three letterproduct code in the product code box. If there are 510(k)’s cleared by FDA andthe new device is substantially equivalent to any of these cleared devices,then the applicant should submit a 510(k).
如果不清楚未分类器械是否需要PMA，请使用三字母的产品代码来搜索预售批准（PMA）数据库和510（k）上市前通知数据库。也可以通过点击产品分类数据库网页顶部的超文本链接来找到这些数据库。在产品代码框中只输入三字母的产品代码。如果FDA清理了510（k），并且新器械基本上等同于任何这些清除的器械，则申请人应提交510（k）。
Furthermore, a new type of device may not befound in the product classification database. If the device is a high riskdevice (supports or sustains human life, is of substantial importance inpreventing impairment of human health, or presents a potential, unreasonablerisk of illness or injury) and has been found to be not substantiallyequivalent (NSE) to a Class I, II, or III [Class III requiring 510(k)] device,then the device must have an approved PMA before marketing in the U.S. Somedevices that are found to be not substantially equivalent to a cleared Class I,II, or III (not requiring PMA) device, may be eligible for the de novo processas a Class I or Class II device. For additional information on the de novoprocess, see the guidance “New section 513(f)(2) - Evaluation ofAutomatic Class III Designation: Guidance for Industry and CDRH Staff”as well as the Evaluation of Automatic Class IIIDesignation (De Novo) Summaries webpage.
此外，在产品分类数据库中可能找不到新类型的器械。如果器械是高风险器械（支持或维持人命，对预防人体健康的损害具有重要意义，或存在潜在的，不合理的疾病或伤害风险）已被发现与I类，II类或III类（需要510（k）的III类）器械基本相当（NSE），则该器械在美国市场销售前必须具有认可的PMA。一些被认定不等同于已清除I类，II类或III类（不需要PMA）的器械可能符合Novo过程为I类或II类器械的资格。有关Novo过程的其他信息，请参阅指导“新增第513（f）（2）条 - 自动III类指定的评估：行业和CDRH工作人员指导”以及自动三级指定评估（De Novo）总结网页。
用于血液的器械企业
The Center for Biologics, Evaluation, andResearch (CBER) has expertise in blood, blood products, and cellular therapiesas well as the integral association of certain medical devices with thesebiological products. To utilize this expertise marketing and investigationaldevice submissions (Premarket Notification, Premarket Approval, andInvestigational Device Exemption) for medical devices associated with the bloodcollection and processing procedures as well as those associated with cellulartherapies are reviewed by CBER. Although these products are reviewed by CBER,the medical device laws and regulations still apply.
生物制剂，评估和研究中心（CBER）具有血液，血液制品和细胞疗法的专业知识，以及某些医疗器械与这些生物制品的整体关联。利用这一专门知识的营销和调查器械提交（上市前通知，上市前批准和调查设备豁免）为与血液收集和处理程序相关的医疗器械以及与细胞疗法相关的医疗器械的上市前通知由CBER审查。虽然这些产品由CBER审查，但医疗器械法律法规仍然适用。
In addition to CDRH guidance on PremarketApproval, please contact CBER for specific medical device guidance fordevices reviewed by CBER at either 1-800-835-4709 or Industry.Biologics@fda.hhs.gov
除了CDRH上市前批准的指导外，请联系CBER，了解CBER审查器械的具体指导，电话1-800-835-4709或邮件Industry.Biologics@fda.hhs.gov。
资料要求
A Premarket Approval (PMA) application is a scientific,regulatory documentation to FDA to demonstrate the safety and effectiveness ofthe class III device. There are administrative elements of a PMA application,but good science and scientific writing is a key to the approval of PMAapplication. If a PMA application lacks elements listed in the administrativechecklist, FDA will refuse to file a PMA application and will not proceed withthe in-depth review of scientific and clinical data. If a PMA application lacksvalid clinical information and scientific analysis on sound scientificreasoning, it could impact FDA's review and approval. PMA applications that areincomplete, inaccurate, inconsist, omit critical information, and poorlyorganized have resulted in delays in approval or denial of PMA applications.Manufacturers should perform a quality control audit of a PMA applicationbefore sending it to FDA to assure that it is scientifically sound andpresented in a well organized format.
上市前批准（PMA）申请程序是一个科学的法规文件，用于证明III类器械的安全性和有效性。有PMA申请的行政要素，但良好的科学和科学写作是PMA申请批准的关键。如果PMA申请程序缺少管理清单中列出的内容，FDA将拒绝提交PMA申请，不会对科学和临床数据进行深入审查。如果PMA申请缺乏有效的临床信息和对科学推理的科学分析，可能会影响FDA的审查和批准。PMA申请程序不完整，不准确，不一致，省略关键信息和组织不良导致PMA批准或拒绝申请程序的延迟。制造商应在将其发送给FDA之前对PMA申请进行质量控制审核，以确保其科学合理，并以有组织的格式呈现。
Technical Sections: The technicalsections containing data and information should allow FDA to determine whetherto approve or disapprove the application. These sections are usually dividedinto non-clinical laboratory studies and clinical investigations.
技术部分：包含数据和信息的技术部分应允许FDA确定是否批准或不批准申请程序。这些部分通常分为非临床实验室研究和临床调查。
Non-clinicalLaboratory Studies Section: Non-clinical laboratory studies section includesinformation on microbiology, toxicology, immunology, biocompatibility, stress,wear, shelf life, and other laboratory or animal tests. Non-clinical studiesfor safety evaluation must be conducted in compliance with 21CFR Part 58 (Good LaboratoryPractice for Nonclinical Laboratory Studies). To assist you in determining theappropriate preclinical bench studies for your device, refer to the applicableguidance documents and standards identified in theProduct Classification databasefor your device. You may also seek input from the review branch via the Pre-Submission Program.
非临床试验研究部分：非临床实验室研究部分包括微生物学，毒理学，免疫学，生物相容性，压力，磨损，保质期和其他实验室或动物试验的信息。非临床研究的安全评估必须按照21CFR第58部分（非临床实验室研究的良好实验室规范）进行。为帮助您确定适用于您器械的临床前试验，请参阅器械产品分类数据库中标识的适用指导文件和标准。您也可以通过预提方案从评审分支机构寻求输入。
ClinicalInvestigations Section: Clinical investigations section includes study protocols,safety and effectiveness data, adverse reactions and complications, devicefailures and replacements, patient information, patient complaints, tabulationsof data from all individual subjects, results of statistical analyses, and anyother information from the clinical investigations. Any investigation conductedunder an Investigational Device Exemption (IDE) mustbe identified as such.
临床调查部分：临床调查部分包括研究方案，安全性和有效性数据，不良反应和并发症，器械故障和替代，患者信息，患者投诉，来自所有个体受试者的数据列表，统计分析结果和临床调查的任何其他信息。根据器械豁免（IDE）进行的任何调查都必须被确定。
Like other scientific reports, FDA hasobserved problems with study designs, study conduct, data analyses,presentations, and conclusions. Investigators should always consult allapplicable FDA guidance documents, industry standards, and recommendedpractices. Numerous device-specific FDA guidance documents that describe datarequirements are available. Study protocols should include allapplicable elements described in the device-specific guidance documents.
与其他科学报告一样，FDA也观察到研究设计，学习行为，数据分析，演示和结论等问题。
调查员应始终咨询所有适用的FDA指导文件，行业标准和推荐做法。描述数据要求的许多器械专用的FDA指导文件都可用。研究协议应包括器械特定指导文件中描述的所有适用元素。
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