谁能提交PMA？
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 of the PMA. This personmay be an individual, partnership, corporation, association, scientific oracademic establishment, government agency or organizational unit, or otherlegal entity. Often times the applicant is the inventor/developer andultimately the manufacturer. If the applicant does notreside or have a place of business within the U.S., the PMA must becountersigned by an authorized representative who does. [§814.20]
PMA申请人通常是用于由FDA提供支持以获得FDA批准的数据和其他信息的权利或以其他方式授权访问的人员。这个人可能是个人，合营公司，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。通常，申请人是发明者/开发商和最终制造商。如果申请人在美国境内没有居住地或营业地点，PMA必须由获得授权的代理人签署。
来自国外临床研究的数据是否被FDA接受？
A study conducted under an investigationaldevice exemption (IDE) outside the United States and submitted in support of aPMA must comply with the IDE regulation (21 CFR 812). A study conductedoutside the U.S. which was not conducted under an IDE must comply with one ofthe following:
根据美国以外的调查器械豁免（IDE）进行的一项研究并提交支持PMA必须遵守IDE规定（21 CFR 812）。在美国以外进行的未在IDE下进行的研究必须符合以下要求之一：
· Research begun on or after effective date November 19, 1986:FDA will accept studies which have been conducted outside the U.S. and begun onor after November 19, 1986, if the data constitute valid scientific evidence (§860.7) and the investigator hasconducted the studies in conformance with the "Declaration ofHelsinki" or the laws and regulations of the country in which the researchwas conducted, whichever offers greater protection to the human subjects. If thestandards of the country are used, the applicant must state in detail anydifferences between those standards and the Declaration of Helsinki and explainwhy the national standards offer greater protection to the human subjects.
· 研究开始于1986年11月19日或之后：FDA将接受在美国以外于1986年11月19日或之后进行的研究，如果数据构成有效的科学证据（§860.7），调查员已经按照“赫尔辛基宣言”或进行研究的国家的法律法规，以对人类受试者提供更大的保护为准。如果使用国家的标准，申请人必须详细说明这些标准与“赫尔辛基宣言”之间的差异，并解释为什么国家标准为人类受试者提供更大的保护。
· Research begun before effectivedate November 19, 1986: FDA will accept studies which have been conductedoutside the U.S. and begun before November 19, 1986, if the agency issatisfied that the data constitute valid scientific evidence (§860.7)and that the rights,safety, and welfare of human subjects have not been violated.
· 研究开始于1986年11月19日之前：FDA将接受在美国以外于1986年11月19日之前进行的研究，如果该机构信息数据构成有效的科学证据（§860.7），并且没有侵犯人类受试者的权利，安全和福利。
· A PMA based solely onforeign clinical data and otherwise meetingthe criteria for approvalunder thispart may be approved if:
· 仅根据国外临床数据和其他符合本部分批准标准的PMA可以批准：
o the foreign data areapplicable to the U.S. population and medical practice;
o 适用于美国人口和医疗实践的国外数据；
o the studies havebeen performed by clinical investigators of recognized competence; and
o 由公认能力的临床研究者进行的研究；和
o the data may beconsidered valid without the need for an on site inspection by FDA or, if FDAconsiders such an inspection to be necessary, FDA can validate the data throughan on site inspection or other appropriate means.
o 可能被认为是有效的数据而不需要FDA进行现场检查，或者如果FDA认为有必要进行检查，则FDA可以通过现场检查或其他适当方式验证数据。
Additional guidance on FDA policy regarding the acceptance offoreign clinical data can be found in the following document.
有关接受外国临床数据的FDA政策的其他指导可以在以下文件中找到。
Acceptance of Foreign Clinical Studies;Guidance for Industry
接受外国临床研究；行业指导
提案者如何通知FDA对正在审核的PMA官方通信者的地址变更？
FDA will send all PMA correspondence only tothe designated official correspondent of the PMA. The sponsor can change thename or address of the official correspondent by submitting an amendment to thePMA.
FDA将所有PMA通信仅发送给PMA指定的官方通信者。提案人可以通过向PMA提交修改来更改官方通信者的姓名或地址。
更改器械的商品名称是否需要FDA批准？
Yes, the sponsor must submit a PMAsupplement and receive approval before the change in trade name can be implemented.
是的，提案人必须提交PMA补充，并在可以实施商业名称变更之前获得批准。
提案者可以将PMA出售给另一家公司吗？所有者如何通知FDA所有权变更？
Yes, a PMA may be sold to another company.The sponsor must submit a PMA amendment to notify FDA of the new owner. The newsponsor is responsible for complying with the PMA regulatory requirements aswell as all other applicable regulations such as registration, listing, qualitysystem, and medical device reporting. The PMA reference number will remain thesame.
Ownership of a PMA may be transferred at anytime, i.e., before or after FDA approval. At the time of the transfer, theformer owner should provide an original and a copy of a letter (preferably onthe letterhead of the former owner and signed by an appropriate companyofficial) to be used to notify FDA that all rights of the PMA have beentransferred to the new owner.
是的，PMA可以出售给另一家公司。提案者必须提交PMA修正案，通知FDA新所有者。新的提案者负责遵守PMA监管要求以及所有其他适用规定，如注册，上市，质量体系和医疗器械报告。PMA参考号将保持不变。PMA的所有权可以在FDA批准之前或之后随时转让。在转让时，前所有者应提供原件和信件（最好在前业主的信头上并由适当的公司官员签名）用于通知FDA，PMA的所有权已转让给新的所有者。
If the PMA has been approved, the new ownerneed only report that the transfer of PMA ownership will not result in a changeor modification that would require a submission of a PMA supplement (§814.39) or affect the conditions ofapproval applicable to the PMA. If changes are made that require a PMAsupplement (§814.39) or affect the conditions ofapproval, the new owner must submit an appropriate PMA supplement and obtainwritten FDA approval before marketing the device.
如果PMA已被批准，新的所有者只需报告PMA所有权的转让不会导致需要提交PMA补充（§814.39）或影响适用于PMA的批准条件的更改或修改。如果进行了需要PMA补充（§814.39）或影响批准条件的更改，新的所有者必须在销售器械之前提交适当的PMA补充并获得FDA书面批准。
The above amendment or supplement shouldalso include:
上述修正或补充也应包括：
· the effective date of the ownership transfer;
· 所有权转让的生效日期；
· a statement of the new owner’s commitment to comply with allthe conditions of approval applicable to the PMA; and
· 新所有者承诺遵守适用于PMA的所有批准条件的声明；和
· either a statement that the new owner has a complete copy ofthe PMA including all amendments, supplements, and reports or a request for acopy from the FDA files. FDA will provide a copy of the PMA under the Freedomof Information fee schedule. [21 CFR 10.42]
· 新的所有者拥有PMA的完整副本的声明，包括所有修订，补充和报告或从FDA复制的文件请求。FDA将根据信息自由日程表提供PMA的副本。
A change in manufacturing or product sterilization site andcertain changes to the device, labeling, or packaging require prior FDAapproval through a PMA supplement. See PMA amendments and supplements forfurther guidance on when a PMA supplement is required.
制造或产品杀菌现场的变化或器械，标签或包装的变更需要经过FDA批准的PMA补充。请参阅PMA修订和补充，以便进一步指导何时需要PMA补充。
If the transfer of ownership occurs before the PMA isapproved, the PMA must be amended to include the applicable information andownership transfer letter described above.
如果所有权转让在PMA批准之前，PMA必须修改，以包括上述适用的信息和所有权转让信。
PMA持有人可以与其他制造商签订许可协议吗？
When the holder of an approved PMA entersinto an agreement to permit another firm (hereafter referred to as thelicensee) to manufacture and distribute a device under the licensee’s privatelabel, FDA approval may be obtained by the following procedure:
当经批准的PMA的持有人签订协议，允许另一家公司（以下简称许可人）根据被许可人的私人标签制造和分销器械时，可以通过以下程序获得FDA批准：
The licensee may submit an original PMA thatincludes, or includes by authorized reference to the holder’s approved PMA, allappropriate information required by 21 CFR 814.20.
许可人可以提交原始PMA，其中包括或通过授权包括许可人批准的PMA，21 CFR 814.20要求的所有适当信息。
After the licensee’s PMA is approved, theoriginal PMA holder may not rescind any authorization permitting the licensee’suse of information in the original approved PMA. The licensee may also use thatsame information in support of changes or modifications later proposed by thelicensee. The licensee becomes independent of the original PMA holder andshould submit all required PMA supplements and periodic postapproval reportsdirectly to FDA.
在许可人的PMA获得批准后，原始PMA许可人可能不会取消任何允许许可人在原始批准的PMA中使用的授权信息。许可人也可以使用相同的信息来支持稍后提出的更改或修改。被许可人独立于原始的PMA持有人，并直接向FDA提交所有必需的PMA补充和定期的批准后报告。
The PMA submission must include thefollowing:
PMA提交必须包括以下内容：
· a statement signed by both parties confirming that theoriginal PMA holder has furnished the licensee with a complete copy of allmanufacturing information in the approved PMA applicable to the licensee’smanufacture of the device;
· 双方签署的声明确认原始PMA持有人向被许可人提供了适用于被许可人制造器械的经批准的PMA中的所有制造信息的完整副本；
· a complete description of a licensee’s manufacturingfacilities and a listing and explanation of all differences between theoriginal PMA holder’s and the licensee’s methods and controls used in themanufacture, processing, packing, storage, and, when appropriate, installationof the device;
· 对被许可人的制造器械的完整描述，以及原始PMA持有人与被许可人在制造，加工，包装，储存以及适当时安装器械时使用的方法和控制之间的所有差异的列表和说明；
· process validation and expiration dating information, whereappropriate;
· 验证过程和到期日期信息；
· copies of all required labeling (draft or final) and adescription of all differences between the PMA holder’s and the licensee’slabeling (e.g., a markup of the PMA holder’s approved labeling identifying therevisions incorporated in the licensee’s labeling;
· 所有必要标签的副本（草稿或最终）以及PMA持有人和被许可人的标签之间所有差异的描述（例如，PMA持有人批准的标签的标识，标识被许可人标签中纳入的修订）；
· a description and the results of all tests and evaluationswhich demonstrate that the licensee’s device is identical or sufficientlysimilar to the PMA holder’s device to the extent that there is reasonableassurance that the licensee’s device is safe and effective for the intendeduse; and
· 说明和所有测试和评估的结果，表明被许可人的器械与PMA持有人的器械相同或足够相似，只要合理确保被许可人的器械对于预期用途是安全有效的；和
· the licensee’s FDA establishment registration number and, ifapplicable, the dates of the most recent FDA inspection of the licensee’smanufacturing facility.
· 被许可人的FDA编制登记号码，以及最近FDA对被许可人制造设施的检查日期（如适用）。
提案者可以更改PMA认证器械的生产基地吗？
Yes, however, the sponsor must receive FDAapproval of the new manufacturing site prior to distributing product that wasmanufactured at the new facility. For additional information about PMAManufacturing Site Change Supplements, contact the Field Inspections SupportBranch in the Division of Analysis and Program Operations (DAPO), Office ofCompliance, at 301-796-5530.
是的，但是提案人必须在分配新器械生产产品之前获得新的生产基地的FDA批准。有关PMA更多制造现场变更补充资料的信息，请联系分析和方案业务司外地检查支助处（DAPO），
合规办公室，301-796-5530。
延长产品保质期是否需要PMA补充？
If FDA has previously reviewed and accepteda protocol for changes to the expiration date and testing was performed inaccordance with that protocol, the change to the expiration date can be madeand reported in an annual report. If not, a PMA supplement should be submitted.
如果FDA以前已经审查并接受了修改到期日期的协议，并按照该协议进行测试， 到期日的变更可以在年度报告中进行报告。如果没有，应提交PMA补充。
如何查看有关PMA的更多信息？
Before FDA approves or disapproves a PMA,FDA will not disclose the existence of the PMA unless it previously has beenpublicly disclosed or acknowledged. Even if the existence of the PMA has beenpublicly disclosed or acknowledged, data or information contained in the fileare not available for public disclosure. However, FDA may disclose a summary ofportions of the safety and effectiveness data, if disclosure is relevant topublic consideration of a specific pending issue. [21 CFR 814, 21 CFR 20]
在FDA批准或不批准PMA之前，除非先前已经公开披露或承认，否则FDA不会披露PMA的存在。即使PMA的存在已被公开披露或承认，文件中包含的数据或信息也不可用于公开披露。然而，如果披露与公众对具体待决问题的考虑相关，FDA可能会披露安全性和有效性数据的一部分。
我可以获得PMA提交的副本吗？
Upon approval (or denial of approval) of anyPMA, FDA will publicly reveal the existence of the PMA and provide a detailedsummary of the information submitted to FDA about the safety and effectivenessof the device. The approval order, summary of safety and effectiveness, andproduct labeling are available on the Internet and are linked from thesearchable PMA database.
任何PMA批准（或拒绝批准）后，FDA将公开披露PMA的存在，并提供有关该器械的安全性和有效性向FDA递交详细信息。批准指令，安全性和有效性总结以及产品标签在互联网上可以找到并可从PMA数据库连接搜索。
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm
In addition, the following types ofinformation in the PMA file are available for public disclosure after deletionof any trade secret, confidential commercial or financial information, or anyother information that if disclosed would constitute a clearly unwarrantedinvasion of personal privacy, e.g., personnel, medical, and similarinformation. The releasable information includes:
此外，在删除任何商业机密后，PMA文件中的以下类型的信息可供公开披露，而机密的商业或财务信息，或任何其他信息，如果被披露将构成明确侵犯个人隐私，例如人员，医疗和类似信息。可披露信息包括：
· all safety and effectiveness data and information previouslydisclosed to the public;
· 之前向公众披露的所有安全和有效性数据和信息；
· any protocol for a test or study;
· 任何测试或研究协议；
· any adverse reaction report, product experience report,consumer complaint, and other similar data and information;
· 任何不良反应报告，产品经验报告，消费者投诉和其他类似的数据和信息；
· a list of components previously disclosed to the public;
· 之前向公众披露的组件清单；
· an assay method or other analytical method; and
· 测定方法或其他分析方法；和
· all correspondenceand writtensummariesof oral discussionrelating to PMA file.
· 关于PMA文件讨论的所有信函和书面摘要。
· The following types of informationare not available for public disclosure unless they have been previously disclosedto the public, relate to a device for which a PMA has been abandoned,or no longerrepresent a trade secret or confidential commercial or financial information:
· 以下类型的信息不可用于公开披露，除非以前向公众披露，涉及已被PMA作废的器械，或不再代表商业秘密或机密的商业或财务信息：
· manufacturing methods or processes including quality controlprocedures;
· 制造方法或过程包括质量控制程序；
· production, sales, distribution, and similar data andinformation; and
· 生产，销售，分销和类似的数据和信息；和
· quantitative or semiquantitative formulas.
· 定量或半定量配方。
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