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發(fā)布本指南是為了符合FDA重新授權(quán)法案2017年(FDARA)(公共法115-52)章節(jié) 702(b)(2)部分，這部分法案指導FDA發(fā)布了關(guān)于官方將如何實施統(tǒng)一的檢查流程和標準，并且適用于除有因檢查外的境內(nèi)和境外器械企業(yè)的檢查。FDA更新流程以及標準，以呼應聯(lián)邦食品、藥品及化妝品法案(FD&C法案)704(h)(1)條新規(guī)定的需求。法案中FDARA章節(jié)702(a)條增加了關(guān)于檢查的標準時間表的要求。本指南還描述了在檢查過程中進行溝通的標準化的方法，并說明了檢查人員和企業(yè)的慣例做法，以促進對此類企業(yè)的持續(xù)檢查。

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，包括這份指南，未確立法律上強制執(zhí)行的責任。相反，指南描述了官方當前對某個主題的考慮，并且應該僅被視為建議，除非引用了特定的法規(guī)或法律要求。在指南中使用的“Should”一詞意味著建議或推薦，但不是強制的要求。

 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，F(xiàn)DARA被簽署成為法律。除其他事項外，F(xiàn)DARA在FD&C法案中增加了章節(jié)704（h）（1）。此部分要求FDA評審流程和標準以適用于境內(nèi)和境外器械企業(yè)的檢查，并更新相關(guān)的檢查流程和標準。必要時通過采用適用于此類檢查的統(tǒng)一的流程和標準。FD＆C法案第704（h）（1）條規(guī)定，更新的統(tǒng)一的流程和標準將描述FDA應該如何在檢查開始前的合理時間內(nèi)預先通知對器械企業(yè)的檢查，提供合理的預計檢查時間表，在檢查過程中需確保與所有者、經(jīng)營者或企業(yè)代表保持定期的溝通。

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）條指示FDA發(fā)布本指南以描述FD&C法案第704（h）（1）條的實施，規(guī)定了標準化的溝通方法，當需要根據(jù)704（h）（1）要求進行溝通時，為檢查建立標準時間表，并確定檢查人員和企業(yè)的操作實踐方法，以促進對此類企業(yè)的持續(xù)檢查。

III. DISCUSSION
3. 討論

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.

根據(jù)FDARA新增的《 FD＆C法案》第704（h）（1）節(jié)，F(xiàn)DA審查了自2017年8月18日起適用于境內(nèi)和境外企業(yè)檢查的流程和標準。審查了包括與企業(yè)檢查有關(guān)的FDA發(fā)布的指南，手冊，程序和內(nèi)部標準操作流程。此次審查，F(xiàn)DA確立了統(tǒng)一的流程和標準，并起草修訂相關(guān)流程文件，包括《檢查操作手冊》和培訓材料，必要時與這些流程和標準保持一致。

FDA believes 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 standardsidentified 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認為，檢查人員在檢查前和檢查期間的統(tǒng)一操作，可以通知企業(yè)做好檢查準備，并為每一方達成基本溝通和時間期望。以下確定的過程和標準應促進鼓勵檢查連續(xù)性和檢查一致性的做法?！禙D＆C法案》第704（h）（1）（A）節(jié)允許FDA酌情確定更新程序和標準的例外情況。

Pre-announcement Notice and Communication
檢查發(fā)布前的通知和溝通

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 bytelep-hone 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 therequire-ments 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將會努力在檢查發(fā)布前事先與企業(yè)取得聯(lián)系?；诮y(tǒng)一的流程和標準，檢查人員在企業(yè)接受檢查之前，將通過電話與企業(yè)的所有者、經(jīng)營者或企業(yè)代表取得聯(lián)系。盡管FDA致力于在檢查前獲得企業(yè)的確認，但FDA認為企業(yè)未對該通知進行確認并不能成為延遲檢查的理由。根據(jù)法規(guī)要求，F(xiàn)DA將在計劃進行檢查之前的合理時間內(nèi)提供此通知。對于境內(nèi)企業(yè)的檢查，檢查通知應至少在檢查前五個自然日發(fā)布。由于特定國家/地區(qū)清關(guān)的要求，境外檢查的通知通常超過五個自然日。對于境內(nèi)和境外檢查，檢查通知應包括檢查類型和檢查性質(zhì)，例如檢查計劃是屬于監(jiān)督檢查還是上市前檢查。

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).

更新的流程規(guī)定，在通知發(fā)布前，檢查人員應與企業(yè)就計劃的檢查時間表和持續(xù)時間進行溝通，包含可以開展檢查的適宜工作時間。FDA還應在可能的情況下對檢查期間可能要求的某些記錄提供預先通知（例如，某些程序文件和任何相關(guān)記錄）。

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

 根據(jù)《FD＆C法案》第704（h）（1）條，F(xiàn)DA保留進行未經(jīng)通知的原因檢查的權(quán)力。

Standard Inspection Timeframe

標準檢查時間表

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 of coverage needed for a pre-approval inspection. The estimated duration for eachinspection should be shared with the firm at the time of preannouncement.Inspection duration is impacted by factors such as the complexities of thefirm’s operations, availability of knowledgeable staff, and the nature ofobserved deficiencies.

FDA規(guī)定的標準檢查時間預計是連續(xù)3至6個工作日。標準時間將基于監(jiān)督檢查的類型（縮略型或綜合型）以及預先批準檢查所需的覆蓋范圍。檢查的持續(xù)時間需要連同通知一并告知企業(yè)。檢查持續(xù)的時間將會根據(jù)諸如企業(yè)運營的復雜性，員工能力以及所觀察到的缺陷的性質(zhì)等因素進行調(diào)整。

Additionally,it may be necessary to extend the duration of an inspection for a number ofreasons, including for FDA to followup 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 thesetimeframes may be appropriate. Exceptionsto the timeframe should be communicated verbally during the course of theinspection.

此外，檢查過程中，出于多種原因，可能有必要延長檢查的持續(xù)時間，其中包括FDA對上市后安全信息的監(jiān)督跟蹤，諸如召回，醫(yī)療器械報告和官方收到的投訴等情況。更新的流程規(guī)定，除非檢查人員或企業(yè)確定需要額外時間，并將原因通過口頭告知對方，否則，對境內(nèi)企業(yè)的檢查應在標準時間內(nèi)進行，且檢查應在連續(xù)的工作日內(nèi)進行。FDA認識到，對于FDA或企業(yè)而言，可能會出現(xiàn)適當?shù)睦馇闆r，在檢查過程中，應以口頭形式進行傳達。

Communication During Inspections
 檢查過程中的溝通

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 andcirc-umstances 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 misunder-standings. 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更新的程序還解決了檢查人員與企業(yè)的所有者、經(jīng)營者或企業(yè)代表應在檢查期間保持適當?shù)臏贤āＴ跁r間和條件允許的情況下，檢查人員應盡一切努力將檢查過程中的觀察結(jié)果與企業(yè)進行討論，最大程度地減少錯誤或誤解。這些討論可能會涉及未在FDA 483表上記錄的需要澄清的觀察結(jié)果。如果有提前通知并且雙方同意，則可以由FDA或企業(yè)記錄溝通情況。

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