I. INTRODUCTION

1.引言

FDAis issuing this guidance to comply with section 702(b)(2) of the FDAReauthorization Act of 2017 (FDARA) (Public Law 115-52), which directs FDA toissue guidance that specifies how the Agency will implement uniform processesand standards that are applicable to inspections (other than for-cause) offoreign and domestic device establishments FDA updated processes and standardsas needed to address the new provisions in section 704(h)(1) of the FederalFood, Drug, and Cosmetic Act (FD&C Act) that were added by FDARA section702(a) and toestablish a standard timeframe for inspections. This guidance alsodescribes standardized methods of communication during the inspection processand identifies practices for investigators and device establishments to facilitatethe continuity of inspections of such establishments.

FDA发布本指南是为了符合FDA重新授权法案2017年(FDARA)(公共法115-52)章节 702(b)(2)部分，这部分法案指导FDA发布了关于官方将如何实施统一的检查流程和标准，并且适用于除有因检查外的境内和境外器械企业的检查。FDA更新流程以及标准，以呼应联邦食品、药品及化妆品法案(FD&C法案)704(h)(1)条新规定的需求。法案中FDARA章节702(a)条增加了关于检查的标准时间表的要求。本指南还描述了在检查过程中进行沟通的标准化的方法，并说明了检查人员和企业的惯例做法，以促进对此类企业的持续检查。

FDA’sguidance documents, including this guidance, do not establish legallyenforceable responsibilities. Instead, guidances describe the Agency’s currentthinking on a topic and should be viewed only as recommendations, unlessspecific regulatory or statutory requirements are cited. The use of the wordshould in Agency guidance means that something is suggested or recommended, butnot required.

FDA的指南文件，包括这份指南，未确立法律上强制执行的责任。相反，指南描述了官方当前对某个主题的考虑，并且应该仅被视为建议，除非引用了特定的法规或法律要求。在指南中使用的“Should”一词意味着建议或推荐，但不是强制的要求。

II. BACKGROUND

2.背景

OnAugust 18, 2017, FDARA was signed into law. Among other things, FDARA addedsection 704(h)(1) to the FD&C Act. This provision requires FDA to reviewprocesses and standards applicable to inspections of domestic and foreigndevice establishments and update such processes and standards, as necessary,through the adoption of uniform processes and standards applicable to suchinspections. Section 704(h)(1) of the FD&C Act specifies that the updateduniform processes and standards will describe how FDA should, among otherthings, pre-announce inspections of device establishments within a reasonabletime before the inspection begins, provide a reasonable estimated timeframe forinspections, and ensure regular communication with the owner, operator, oragent in charge of the establishment during inspections.

2017年8月18日，FDARA被签署成为法律。除其他事项外，FDARA在FD&C法案中增加了章节704（h）（1）。此部分要求FDA评审流程和标准以适用于境内和境外器械企业的检查，并更新相关的检查流程和标准。必要时通过采用适用于此类检查的统一的流程和标准。FD＆C法案第704（h）（1）条规定，更新的统一的流程和标准将描述FDA应该如何在检查开始前的合理时间内预先通知对器械企业的检查，提供合理的预计检查时间表，在检查过程中需确保与所有者、经营者或企业代表保持定期的沟通。

Section702(b) of FDARA instructs FDA to issue this guidance to describe how it isimplementing section 704(h)(1) of the FD&C Act, provide for standardizedmethods of communication when communication is required under 704(h)(1),establish a standard timeframe for inspections, and identify practices forinvestigators and device establishments to facilitate the continuity of inspectionsof such establishments.

FDARA第702（b）条指示FDA发布本指南以描述FD&C法案第704（h）（1）条的实施，规定了标准化的沟通方法，当需要根据704（h）（1）要求进行沟通时，为检查建立标准时间表，并确定检查人员和企业的操作实践方法，以促进对此类企业的持续检查。

III. DISCUSSION

3. 讨论

Pursuantto section 704(h)(1) of the FD&C Act, as added by FDARA, FDA reviewed theprocesses and standards applicable to inspections of foreign and domesticdevice establishments that were in place as of August 18, 2017. The reviewencompassed FDA guidances, manuals, programs, and internal standard operatingprocedures related to device establishment inspections. As a result of thisreview, FDA identified uniform processes and standards and drafted revisions toupdate procedural documents, including the Investigations Operations Manual andtraining materials, where necessary, to align with these processes andstandards.

根据FDARA新增的《 FD＆C法案》第704（h）（1）节，FDA审查了自2017年8月18日起适用于境内和境外企业检查的流程和标准。审查了包括与企业检查有关的FDA发布的指南，手册，程序和内部标准操作流程。此次审查，FDA确立了统一的流程和标准，并起草修订相关流程文件，包括《检查操作手册》和培训材料，必要时与这些流程和标准保持一致。

FDAbelieves that uniformity in investigators’ approaches to inspections, bothbefore and during, may inform firms’ preparation for the inspection and setbaseline communication and timing expectations for each party. The processesand standards identified below should facilitate practices that encouragecontinuity within an inspection and consistency across inspections. Section704(h)(1)(A) of the FD&C Act allows FDA to establish exceptions to theupdated processes and standards, as appropriate.

FDA认为，检查人员在检查前和检查期间的统一操作，可以通知企业做好检查准备，并为每一方达成基本沟通和时间期望。以下确定的过程和标准应促进鼓励检查连续性和检查一致性的做法。《FD＆C法案》第704（h）（1）（A）节允许FDA酌情确定更新程序和标准的例外情况。

Pre-announcement Notice and Communication

检查发布前的通知和沟通

FDAintends to make reasonable efforts to make contact with the firm to preannouncethe inspection. Under the uniform processes and standards, an investigatornotifies the owner, operator, or agent in charge of a device establishment bytelephone before their facility undergoes an inspection. While FDA intends toseek acknowledgement of the pre-announcement notification from the firm, FDAbelieves the firm’s failure to acknowledge the notification should not be areason to delay the start of an inspection. Under the statute, thisnotification will be provided within a reasonable time before the inspection isscheduled to occur. For domestic inspections, the pre-announcement should be noless than five calendar days in advance of the inspection. The pre-announcementfor foreign inspections is generally more than five calendar days due to therequirements of particular country clearances. For both domestic and foreigninspections, the notification should include information about the type andnature of the inspection, such as whether the inspection is scheduled as surveillanceor pre-approval.

FDA将会努力在检查发布前事先与企业取得联系。基于统一的流程和标准，检查人员在企业接受检查之前，将通过电话与企业的所有者、经营者或企业代表取得联系。尽管FDA致力于在检查前获得企业的确认，但FDA认为企业未对该通知进行确认并不能成为延迟检查的理由。根据法规要求，FDA将在计划进行检查之前的合理时间内提供此通知。对于境内企业的检查，检查通知应至少在检查前五个自然日发布。由于特定国家/地区清关的要求，境外检查的通知通常超过五个自然日。对于境内和境外检查，检查通知应包括检查类型和检查性质，例如检查计划是属于监督检查还是上市前检查。

Updatedprocesses specify that during pre-announcement, investigators shouldcommunicate with the firm regarding the planned timeframe and duration of theinspection, to include appropriate working hours during which the inspection islikely to take place. To the extent possible, FDA should also provide advancenotice of some records that may be requested during the inspection (e.g.,certain procedures and any associated records).

更新的流程规定，在通知发布前，检查人员应与企业就计划的检查时间表和持续时间进行沟通，包含可以开展检查的适宜工作时间。FDA还应在可能的情况下对检查期间可能要求的某些记录提供预先通知（例如，某些程序文件和任何相关记录）。

Under704(h)(1) of the FD&C Act, FDA retains authority to conduct unannounced,for-cause inspections.

根据《FD＆C法案》第704（h）（1）条，FDA保留进行未经通知的原因检查的权力。

Standard Inspection Timeframe

标准检查时间表

FDAstandards for reasonable estimated timeframes of inspections generally rangefrom 3 to 6 continuous business days. These standards are based on the type ofsurveillance inspection (abbreviated or comprehensive) and the extent ofcoverage needed for a pre-approval inspection. The estimated duration for eachinspection should be shared with the firm at the time of pre-announcement.Inspection duration is impacted by factors such as the complexities of thefirm’s operations, availability of knowledgeable staff, and the nature ofobserved deficiencies.

FDA规定的标准检查时间预计是连续3至6个工作日。标准时间将基于监督检查的类型（缩略型或综合型）以及预先批准检查所需的覆盖范围。检查的持续时间需要连同通知一并告知企业。检查持续的时间将会根据诸如企业运营的复杂性，员工能力以及所观察到的缺陷的性质等因素进行调整。

Additionally,it may be necessary to extend the duration of an inspection for a number ofreasons, including for FDA to follow-up on post-market safety information suchas recalls, Medical Device Reports, and complaints received by the Agency.Updated processes provide that, unless an investigator or the firm identifies areason that additional time is needed and communicates this verbally to theother party, inspections of both domestic and foreign device establishmentsshould take place within a standard timeframe and occur over consecutivebusiness days. FDA recognizes that circumstances may arise, for either FDA orthe firm, where exceptions to these timeframes may be appropriate. Exceptionsto the timeframe should be communicated verbally during the course of theinspection.

此外，检查过程中，出于多种原因，可能有必要延长检查的持续时间，其中包括FDA对上市后安全信息的监督跟踪，诸如召回，医疗器械报告和官方收到的投诉等情况。更新的流程规定，除非检查人员或企业确定需要额外时间，并将原因通过口头告知对方，否则，对境内企业的检查应在标准时间内进行，且检查应在连续的工作日内进行。FDA认识到，对于FDA或企业而言，可能会出现适当的例外情况，在检查过程中，应以口头形式进行传达。

Communication During Inspections

检查过程中的沟通

FDA’supdated processes also address regular verbal communications during theinspection between the investigator and the owner, operator, or agent in chargeof the device establishment about the status of the inspection. When time andcircumstances permit, investigators should make every reasonable effort todiscuss all observations with the owner, operator, or agent in charge of thedevice establishment as they are observed, or on a daily basis, to minimizeerrors and misunderstandings. These discussions may address observations notdocumented on the FDA Form 483 that require clarification. Communications maybe recorded by either FDA or the firm, if there is advance notice and mutualconsent by the other party.

FDA更新的程序还解决了检查人员与企业的所有者、经营者或企业代表应在检查期间保持适当的沟通。在时间和条件允许的情况下，检查人员应尽一切努力将检查过程中的观察结果与企业进行讨论，最大程度地减少错误或误解。这些讨论可能会涉及未在FDA 483表上记录的需要澄清的观察结果。如果有提前通知并且双方同意，则可以由FDA或企业记录沟通情况。