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近日，F(xiàn)DA 發(fā)布了《行業(yè)指南：遠(yuǎn)程監(jiān)管評(píng)估（RRA）指南—問(wèn)答》，該指南將遠(yuǎn)程監(jiān)管評(píng)估（RRA）正式確立為常態(tài)化監(jiān)管工具 —— 文件包含：哪些主體可能受到遠(yuǎn)程監(jiān)管評(píng)估？遠(yuǎn)程監(jiān)管評(píng)估是否正在取代其他既定的非檢查獲取信息的方式？FDA何時(shí)可能啟動(dòng)或要求進(jìn)行遠(yuǎn)程監(jiān)管評(píng)估？遠(yuǎn)程監(jiān)管評(píng)估的要求？企業(yè)在遠(yuǎn)程監(jiān)管評(píng)估期間可能預(yù)期會(huì)發(fā)生什么？遠(yuǎn)程監(jiān)管評(píng)估完成后可能會(huì)發(fā)生什么？等問(wèn)題的解答：
以下為指南的原文及其翻譯
Guidance for Industry
行業(yè)指南
Conducting Remote Regulatory Assessments
開展遠(yuǎn)程監(jiān)管評(píng)估
Questions and Answers
問(wèn)答
June 2025
2025年6月
Table of Contents目錄
I. Introduction一、介紹
II. Background二、背景
III. Questions and Answers三、問(wèn)答
A. Remote Regulatory Assessment FundamentalsA. 遠(yuǎn)程監(jiān)管評(píng)估基礎(chǔ)
1. What is an RRA?1. 什么是遠(yuǎn)程監(jiān)管評(píng)估（RRA）？
2. Who may be subject to an RRA?2. 哪些主體可能接受遠(yuǎn)程監(jiān)管評(píng)估？
3. Are RRAs replacing other established means of obtaining information outside of inspections?3. 遠(yuǎn)程監(jiān)管評(píng)估是否正在取代其他既定的非檢查獲取信息的方式？
4. Is an RRA an inspection?4. 遠(yuǎn)程監(jiān)管評(píng)估是一種檢查嗎？
5. When may FDA initiate or request to conduct an RRA?5. 美國(guó)食品藥品監(jiān)督管理局（FDA）何時(shí)可能啟動(dòng)或要求進(jìn)行遠(yuǎn)程監(jiān)管評(píng)估？
6. Will FDA use RRAs during or as part of an FDA inspection of an establishment?6. FDA 在對(duì)企業(yè)進(jìn)行檢查期間或作為檢查的一部分時(shí)會(huì)使用遠(yuǎn)程監(jiān)管評(píng)估嗎？
7. What are the benefits of an RRA?7. 遠(yuǎn)程監(jiān)管評(píng)估的好處是什么？B. Remote Regulatory Assessment ExpectationsB. 遠(yuǎn)程監(jiān)管評(píng)估預(yù)期
8. How may FDA request an RRA?8. FDA 如何要求進(jìn)行遠(yuǎn)程監(jiān)管評(píng)估？
9. What might an establishment expect to happen during an RRA?9. 企業(yè)在遠(yuǎn)程監(jiān)管評(píng)估期間可能預(yù)期會(huì)發(fā)生什么？
10. Are there any consequences for declining to participate in an RRA?10. 拒絕參與遠(yuǎn)程監(jiān)管評(píng)估會(huì)有什么后果？
11. Are there any technological expectations for an RRA?11. 對(duì)遠(yuǎn)程監(jiān)管評(píng)估有哪些技術(shù)方面的預(yù)期？C. Requests for Records or Other Information as Part of Remote Regulatory AssessmentsC. 作為遠(yuǎn)程監(jiān)管評(píng)估一部分的記錄或其他信息請(qǐng)求
12. What records or other information may FDA request as part of an RRA?12. FDA 作為遠(yuǎn)程監(jiān)管評(píng)估的一部分可能會(huì)要求哪些記錄或其他信息？
13. For what purposes may FDA use the records and other information gathered during an RRA?13. FDA 使用在遠(yuǎn)程監(jiān)管評(píng)估期間收集的記錄和其他信息的目的是什么？
14. If the RRA requests records or other information, what is the timeframe for submitting the records and other information to FDA?14. 如果遠(yuǎn)程監(jiān)管評(píng)估要求提供記錄或其他信息，向 FDA 提交這些記錄和其他信息的時(shí)間框架是怎樣的？
15. How should records or other information in response to an RRA request be provided to FDA?15. 應(yīng)如何向 FDA 提供對(duì)遠(yuǎn)程監(jiān)管評(píng)估請(qǐng)求作出回應(yīng)的記錄或其他信息？D. Completion of a Remote Regulatory AssessmentD. 遠(yuǎn)程監(jiān)管評(píng)估的完成
16. What may occur upon completion of an RRA?16. 遠(yuǎn)程監(jiān)管評(píng)估完成后可能會(huì)發(fā)生什么？
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page.
本指南代表了FDA 對(duì)該主題的當(dāng)前想法。它不會(huì)為任何人確立任何權(quán)利，對(duì) FDA 或公眾也沒有約束力。如果滿足適用法規(guī)的要求，您可以采用替代方法。若要討論替代方法，請(qǐng)聯(lián)系標(biāo)題頁(yè)所列負(fù)責(zé)本指南的 FDA 工作人員或辦公室。
I. Introduction一、引言
In response to the Coronavirus Disease 2019 (COVID - 19) pandemic, FDA adapted its operations for field activities to provide oversight of regulated industry while mitigating the spread of COVID - 19. One set of tools used during the COVID - 19 public health emergency for oversight of FDA - regulated products was remote regulatory assessments (RRAs). The term “RRA” (as defined in the Question and Answers section) is used to describe a category of activities for which FDA may use different terminologies, but that are all considered to be types of RRAs, including “remote interactive evaluations” and “remote record reviews.” Such activities, along with others identified in this guidance, are considered RRAs for purposes of this guidance. When faced with travel restrictions during the COVID - 19 pandemic, FDA used RRAs to assess establishments and their compliance with applicable FDA requirements. Based on this experience FDA has noted the value of RRAs and concluded that they are a beneficial oversight tool outside the COVID - 19 pandemic and for a range of FDA - regulated products.FDA has developed this guidance to provide answers to frequently asked questions related to RRAs. This guidance is intended to help enhance industry's understanding of RRAs, thereby facilitating FDA's process for conducting RRAs. The guidance finalizes the revised draft guidance of the same title issued on January 26, 2024 (89 FR 5244).
為應(yīng)對(duì) 2019 冠狀病毒病（COVID - 19）大流行，F(xiàn)DA 調(diào)整了其現(xiàn)場(chǎng)活動(dòng)的操作方式，以便在減輕 COVID - 19 傳播的同時(shí)對(duì)受監(jiān)管行業(yè)進(jìn)行監(jiān)督。在 COVID - 19 公共衛(wèi)生緊急事件期間，用于監(jiān)督 FDA 監(jiān)管產(chǎn)品的一套工具是遠(yuǎn)程監(jiān)管評(píng)估（RRAs）。“RRA” 一詞（在問(wèn)答部分定義）用于描述一類活動(dòng)，F(xiàn)DA 可能會(huì)使用不同術(shù)語(yǔ)來(lái)稱呼這類活動(dòng)，但它們都被視為 RRA 的類型，包括 “遠(yuǎn)程互動(dòng)評(píng)估” 和 “遠(yuǎn)程記錄審查”。就本指南而言，此類活動(dòng)以及本指南中確定的其他活動(dòng)被視為 RRA。在 COVID - 19 大流行期間面臨旅行限制時(shí)，F(xiàn)DA 使用 RRA 來(lái)評(píng)估企業(yè)及其對(duì)適用 FDA 要求的合規(guī)情況。基于這一經(jīng)驗(yàn)，美國(guó)食品藥品監(jiān)督管理局（FDA）已認(rèn)識(shí)到遠(yuǎn)程監(jiān)管評(píng)估（RRAs）的價(jià)值，并得出結(jié)論：在新冠疫情之外，對(duì)于一系列 FDA 監(jiān)管的產(chǎn)品而言，RRAs 是一種有益的監(jiān)管工具。FDA 制定了本指南，以解答與 RRAs 相關(guān)的常見問(wèn)題。本指南旨在幫助加強(qiáng)行業(yè)對(duì) RRAs 的理解，從而促進(jìn) FDA 開展 RRAs 的流程。該指南最終確定了 2024 年 1 月 26 日發(fā)布的同名修訂草案指南（《聯(lián)邦公報(bào)》第 89 卷，第 5244 頁(yè)）。
Throughout this guidance, the terms, “FDA,” “the Agency,” “we,” “us,” and “our” refer to the Food and Drug Administration. In this guidance, the term “establishment” includes any facility, entity, person, importer, or site, whether foreign or domestic, subject to the laws administered by FDA.在本指南中，“FDA”、“機(jī)構(gòu)”、“我們”、“我們的” 等術(shù)語(yǔ)均指美國(guó)食品藥品監(jiān)督管理局（Food and Drug Administration）。在本指南中，“企業(yè)” 一詞包括受 FDA 監(jiān)管法律約束的任何場(chǎng)所、實(shí)體、個(gè)人、進(jìn)口商或地點(diǎn)，無(wú)論其位于國(guó)外還是國(guó)內(nèi)。
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended but not required.FDA 的指南文件，包括本指南，并不構(gòu)成具有法律強(qiáng)制執(zhí)行力的責(zé)任。相反，指南文件描述了我們對(duì)某一主題的當(dāng)前想法，應(yīng)僅被視為建議，除非引用了特定的法規(guī)或法定要求。機(jī)構(gòu)指南中 “應(yīng)該”（should）一詞的使用意味著某事物是被建議或推薦的，而非強(qiáng)制要求的。
Ⅱ. Background二、背景
FDA uses a variety of tools5 for oversight of FDA-regulated products and establishments. During the COVID-19 pandemic, FDA used RRAs to help the Agency conduct oversight, mitigate risk, and meet critical public health needs with respect to certain FDA-regulated products. RRAs have included: (1) mandatory6 RRAs involving review of records or other information submitted by certain establishments upon request from FDA under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); (2) mandatory reviews of records from food importers subject to section 805 of the FD&C Act 7 (hereinafter referred to as “requests for Foreign Supplier Verification Program (FSVP) records under 21 CFR 1.510(b)(3) or 1.512(b)(5)(ii)(C)”); and (3) voluntary RRAs involving remote requests for records and/or interactive evaluations (such as remote livestreaming video of operations, teleconferences, and screen sharing).FDA 使用多種工具對(duì)受其監(jiān)管的產(chǎn)品和企業(yè)進(jìn)行監(jiān)督。在新冠疫情期間，F(xiàn)DA 使用遠(yuǎn)程評(píng)估（RRAs）來(lái)幫助該機(jī)構(gòu)進(jìn)行監(jiān)督、降低風(fēng)險(xiǎn)，并滿足對(duì)某些受 FDA 監(jiān)管產(chǎn)品的關(guān)鍵公共衛(wèi)生需求。遠(yuǎn)程評(píng)估包括：（1）根據(jù)《聯(lián)邦食品、藥品和化妝品法案》（FD&C 法案）第 704 (a)(4) 條，應(yīng) FDA 要求，某些企業(yè)提交的記錄或其他信息的強(qiáng)制性遠(yuǎn)程評(píng)估；（2）根據(jù)《聯(lián)邦食品、藥品和化妝品法案》第 805 條（以下簡(jiǎn)稱 “外國(guó)供應(yīng)商驗(yàn)證計(jì)劃（FSVP）記錄要求”，見 21 CFR 1.510 (b)(3) 或 1.512 (b)(5)(ii)(C)'）對(duì)食品進(jìn)口商記錄的強(qiáng)制性審查；以及（3）涉及遠(yuǎn)程記錄請(qǐng)求和 / 或互動(dòng)評(píng)估（如遠(yuǎn)程操作視頻直播、電話會(huì)議和屏幕共享）的自愿遠(yuǎn)程評(píng)估。
FDA has identified significant benefits in using RRAs. For instance, RRAs have assisted FDA in verifying corrective actions taken in response to inspections of previously compliant manufacturers8 and in gaining compliance insight when it was not practicable to inspect. RRAs have also provided information about deficient practices, leading FDA to take regulatory actions and/or conduct inspections, as well as informing future inspection planning. RRAs were used to help support review and promote timely approval or authorization of marketing submissions for FDA-regulated products. In the food programs, RRAs have assisted in determining compliance with veterinary feed directive regulations, assessing foreign manufacturing process records, adding foreign establishments to import alerts, and issuing warning letters.美國(guó)食品藥品監(jiān)督管理局（FDA）已確定使用遠(yuǎn)程評(píng)估（RRAs）具有顯著益處。例如，遠(yuǎn)程評(píng)估協(xié)助 FDA 核實(shí)先前合規(guī)的制造商針對(duì)檢查所采取的糾正措施，并在實(shí)地檢查不可行時(shí)獲取合規(guī)情況的見解。遠(yuǎn)程評(píng)估還提供了有關(guān)缺陷做法的信息，促使 FDA 采取監(jiān)管行動(dòng)和 / 或進(jìn)行檢查，同時(shí)也為未來(lái)的檢查規(guī)劃提供信息。遠(yuǎn)程評(píng)估被用于支持審查并促進(jìn)及時(shí)改進(jìn)或糾正營(yíng)銷宣傳聲明。在食品計(jì)劃中，遠(yuǎn)程評(píng)估有助于確定是否符合獸藥飼料指令法規(guī)，評(píng)估國(guó)外生產(chǎn)過(guò)程記錄，將國(guó)外機(jī)構(gòu)添加到進(jìn)口預(yù)警名單中，以及發(fā)布警告信。
Based on these experiences, FDA has determined that RRAs are valuable oversight tools and, therefore, under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements.基于這些經(jīng)驗(yàn)，F(xiàn)DA 認(rèn)定遠(yuǎn)程評(píng)估是有價(jià)值的監(jiān)管工具，因此，在某些情況下，能夠協(xié)助 FDA 履行保護(hù)公眾健康、監(jiān)督受監(jiān)管行業(yè)以及確保受監(jiān)管產(chǎn)品符合 FDA 要求的使命。
With respect to section 704(a)(4) of the FD&C Act, this provision, as amended by the Food and Drug Omnibus Reform Act of 2022 (FDORA),9 gives FDA authority to request (and requires establishments to provide) any records or other information that FDA may inspect under section 704 of the FD&C Act, in advance of or in lieu of inspections of such establishments that engage in the manufacture, preparation, propagation, compounding, or processing of a drug or device,10 or a site or facility that is subject to inspection under section 704(a)(5)(C) of the FD&C Act (i.e., sites, entities, or facilities subject to bioresearch monitoring (BIMO) inspections).關(guān)于《聯(lián)邦食品、藥品和化妝品法案》（FD&C Act）第 704 (a)(4) 條，經(jīng) 2022 年《食品藥品綜合改革法案》（FDORA）修訂后的該條款，賦予 FDA 權(quán)力要求（并要求相關(guān)機(jī)構(gòu)提供）FDA 根據(jù)《聯(lián)邦食品、藥品和化妝品法案》第 704 條在檢查之前可能檢查的任何記錄或其他信息，前提是這些機(jī)構(gòu)參與藥品或器械的制造、制備、傳播、調(diào)配或加工，或參與受《聯(lián)邦食品、藥品和化妝品法案》第 704 (a)(5)(C) 條檢查的生物研究監(jiān)測(cè)（BIMO）檢查的場(chǎng)所或設(shè)施（即受此類檢查的場(chǎng)所、實(shí)體或設(shè)施）。
The Agency believes that FDA’s use of both mandatory and voluntary RRAs, as applicable, for FDA- regulated products is in the interest of the public health, and the Agency is issuing this guidance to provide further transparency to interested parties about the circumstances in which the Agency may opt to use mandatory and voluntary RRAs.該機(jī)構(gòu)認(rèn)為，F(xiàn)DA 在適用情況下對(duì)受其監(jiān)管的產(chǎn)品同時(shí)使用強(qiáng)制性和自愿性遠(yuǎn)程評(píng)估，符合公眾健康利益，并且該機(jī)構(gòu)發(fā)布本指南是為了向相關(guān)方進(jìn)一步說(shuō)明該機(jī)構(gòu)可能選擇使用強(qiáng)制性和自愿性遠(yuǎn)程評(píng)估的情形。
The Agency is also issuing this guidance to promote greater consistency in the manner RRAs are conducted, including by explaining processes for responding to an RRA request, and by outlining factors we use for evaluating whether an establishment has responded timely and appropriately to a mandatory request.該機(jī)構(gòu)發(fā)布本指南也是為了促進(jìn)遠(yuǎn)程評(píng)估實(shí)施方式的更大一致性，包括解釋對(duì)遠(yuǎn)程評(píng)估請(qǐng)求的回應(yīng)流程，以及概述用于評(píng)估機(jī)構(gòu)是否及時(shí)、適當(dāng)?shù)鼗貞?yīng)強(qiáng)制性遠(yuǎn)程評(píng)估請(qǐng)求的因素。
Ⅲ. Questions and Answers三、問(wèn)答
This section is intended to provide FDA’s current thinking regarding the requesting, conducting, and use of RRAs by FDA.本節(jié)旨在提供美國(guó)食品藥品監(jiān)督管理局（FDA）目前對(duì)于請(qǐng)求、開展和使用遠(yuǎn)程監(jiān)管評(píng)估（RRA）的想法。
A.Remote Regulatory Assessment FundamentalsA. 遠(yuǎn)程監(jiān)管評(píng)估基本原理
1.What is an RRA?1.什么是遠(yuǎn)程監(jiān)管評(píng)估（RRA）？
An RRA is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements. RRAs assist in protecting human and animal health, informing regulatory decisions, and verifying certain information submitted to the Agency.遠(yuǎn)程監(jiān)管評(píng)估是對(duì)受 FDA 監(jiān)管的機(jī)構(gòu)及其記錄進(jìn)行的完全遠(yuǎn)程檢查，以評(píng)估其是否符合適用的 FDA 要求。遠(yuǎn)程監(jiān)管評(píng)估有助于保護(hù)人類和動(dòng)物健康，為監(jiān)管決策提供信息，并核實(shí)提交給該機(jī)構(gòu)的某些信息。
RRAs are a tool FDA may use to support regulatory decisions and oversight activities. Mandatory RRAs are those conducted under legal authorities mandating the establishment’s participation. Requests for records or other information from establishments subject to section 704(a)(4) of the FD&C Act, and requests for FSVP records under 21 CFR 1.510(b)(3) and 1.512(b)(5)(ii)(C), are included among mandatory RRAs.11 RRAs that are not conducted under statutory or regulatory authorities mandating an establishment’s participation are voluntary in that an establishment can decline to participate or withdraw participation during the RRA, in which case the Agency may consider other tools for evaluating compliance with FDA requirements.遠(yuǎn)程監(jiān)管評(píng)估是 FDA 可用于支持監(jiān)管決策和監(jiān)督活動(dòng)的一種工具。強(qiáng)制性遠(yuǎn)程監(jiān)管評(píng)估是指根據(jù)法律授權(quán)要求機(jī)構(gòu)參與的評(píng)估。根據(jù)《聯(lián)邦食品、藥品和化妝品法案》（FD&C Act）第 704 (a)(4) 節(jié)向機(jī)構(gòu)索取記錄或其他信息的請(qǐng)求，以及根據(jù)《聯(lián)邦法規(guī)匯編》（CFR）第 21 篇第 1.510 (b)(3) 和 1.512 (b)(5)(ii)(C) 節(jié)對(duì)外國(guó)供應(yīng)商驗(yàn)證計(jì)劃（FSVP）記錄的請(qǐng)求，均屬于強(qiáng)制性遠(yuǎn)程監(jiān)管評(píng)估。在沒有法定或監(jiān)管授權(quán)要求機(jī)構(gòu)參與遠(yuǎn)程監(jiān)管評(píng)估的情況下進(jìn)行的遠(yuǎn)程監(jiān)管評(píng)估是自愿性的，在這種情況下，機(jī)構(gòu)可以選擇不參與或退出，此時(shí) FDA 可能會(huì)考慮使用其他工具來(lái)評(píng)估其是否符合 FDA 的要求。
RRAs complement FDA’s authority to conduct inspections under section 704(a)(1) of the FD&C Act and other applicable FDA authorities. RRAs do not limit the authority of FDA to conduct inspections under section 704(a)(1) of the FD&C Act and other applicable FDA authorities.
遠(yuǎn)程監(jiān)管評(píng)估補(bǔ)充了 FDA 根據(jù)《FD&C Act》第 704 (a)(1) 節(jié)及其他適用的 FDA 授權(quán)進(jìn)行檢查的權(quán)力。遠(yuǎn)程監(jiān)管評(píng)估并不限制 FDA 根據(jù)《FD&C Act》第 704 (a)(1) 節(jié)及其他適用的 FDA 授權(quán)進(jìn)行檢查的權(quán)力。
2.Who may be subject to an RRA?
2.哪些對(duì)象可能接受遠(yuǎn)程監(jiān)管評(píng)估？
·Mandatory RRAs·強(qiáng)制性遠(yuǎn)程監(jiān)管評(píng)估
Mandatory RRAs include those conducted for: (1) establishments that are subject to section 704(a)(4) of the FD&C Act;12 and (2) importers, as defined in 21 CFR 1.500, that are subject to FSVP under section 805 of the FD&C Act and to the records review requirements in 21 CFR 1.510(b)(3) or 1.512(b)(5)(ii)(C) , as applicable.
強(qiáng)制性遠(yuǎn)程監(jiān)管評(píng)估包括以下情況：(1) 受《FD&C Act》第 704 (a)(4) 節(jié)約束的機(jī)構(gòu)；(2) 如《CFR》第 21 篇第 1.500 節(jié)所定義的進(jìn)口商，其受《FD&C Act》第 805 節(jié)下的外國(guó)供應(yīng)商驗(yàn)證計(jì)劃（FSVP）以及《CFR》第 21 篇第 1.510 (b)(3) 或 1.512 (b)(5)(ii)(C) 節(jié)中記錄審查要求的約束（如適用）。
Upon initiating a mandatory RRA, FDA intends to make clear the authorities under which the RRA is being requested.
在啟動(dòng)強(qiáng)制性遠(yuǎn)程監(jiān)管評(píng)估時(shí)，F(xiàn)DA 打算明確提出該評(píng)估所依據(jù)的授權(quán)。
·Voluntary RRAs·自愿性遠(yuǎn)程監(jiān)管評(píng)估（RRA）
If an RRA is not mandated by statute or regulation (or FDA opts against exercising its mandatory RRA authority in a certain instance), FDA may request that any establishment subject to FDA jurisdiction participate in a voluntary RRA.
如果一項(xiàng)RRA并非由法規(guī)或條例強(qiáng)制要求（或者美國(guó)食品藥品監(jiān)督管理局（FDA）在特定情況下選擇不行使其強(qiáng)制RRA權(quán)力），F(xiàn)DA 可能會(huì)要求受其管轄的任何企業(yè)參與自愿性遠(yuǎn)程監(jiān)管評(píng)估。
3.Are RRAs replacing other established means of obtaining information outside of inspections?
3. 遠(yuǎn)程監(jiān)管評(píng)估是否正在取代檢查之外的其他既定信息獲取方式？
No, RRAs are not intended to limit or replace other established means of obtaining information necessary for FDA to accomplish its public health mission outside of inspections, including, among other things, applicant information request letters, registration information and updates meetings, product submissions, application assessments, or follow-up communications during outbreaks or other emergencies. Similarly, if, for example, FDA contacts an applicant to inform it that an application or other submission is missing certain information, this is not an RRA. Although these activities may be conducted remotely, the Agency does not consider these activities to be RRAs.
不，遠(yuǎn)程監(jiān)管評(píng)估并非旨在限制或取代 FDA 在檢查之外為實(shí)現(xiàn)其公共衛(wèi)生使命所需的其他既定信息獲取方式，其中包括但不限于申請(qǐng)函、監(jiān)管信息請(qǐng)求、更新會(huì)議、產(chǎn)品申報(bào)、申請(qǐng)?jiān)u估，或在疫情爆發(fā)或其他緊急情況下的跟進(jìn)溝通。同樣，例如，如果 FDA 聯(lián)系申請(qǐng)人告知其某項(xiàng)申請(qǐng)或其他申報(bào)缺少某些信息，這些活動(dòng)并非遠(yuǎn)程遠(yuǎn)程監(jiān)管評(píng)估。盡管這些活動(dòng)可能以遠(yuǎn)程方式進(jìn)行，但 FDA 并不將其視為遠(yuǎn)程監(jiān)管評(píng)估。
4. Is an RRA an inspection?
4. 遠(yuǎn)程監(jiān)管評(píng)估是一種檢查嗎？
An RRA is not an inspection under sections 704(a)(1) or 704(a)(5) of the FD&C Act. Generally, an inspection, such as described in section 704(a)(1) of the FD&C Act, involves duly designated officers or employees of the FDA physically entering (at reasonable times and in a reasonable manner), establishments subject to regulation under the FD&C Act to determine compliance with applicable requirements.
遠(yuǎn)程監(jiān)管評(píng)估并非《聯(lián)邦食品、藥品和化妝品法案》（FD&C Act）第 704 (a)(1) 或 704 (a)(5) 節(jié)所定義的檢查。一般而言，如 FD&C 法案第 704 (a)(1) 節(jié)所述的檢查，涉及 FDA 正式指定的官員或雇員（在合理時(shí)間以合理方式）實(shí)際進(jìn)入受 FD&C 法案監(jiān)管的企業(yè)，以確定其是否符合適用要求。
However, because remote requests for FSVP records are under the authority of section 805 of the FD&C Act and FDA’s implementing regulations,16 these record requests function as inspections in that FDA uses these record requests to evaluate a food importer’s compliance with FSVP.
然而，由于對(duì)外國(guó)供應(yīng)商驗(yàn)證計(jì)劃（FSVP）記錄的遠(yuǎn)程請(qǐng)求是依據(jù) FD&C 法案第 805 節(jié)以及 FDA 的實(shí)施條例授權(quán)進(jìn)行的，這些記錄請(qǐng)求在功能上等同于檢查，因?yàn)?FDA 利用這些記錄請(qǐng)求來(lái)評(píng)估食品進(jìn)口商是否遵守 FSVP 要求。
5.When may FDA initiate or request to conduct an RRA?
5. FDA 何時(shí)可以發(fā)起或要求進(jìn)行遠(yuǎn)程監(jiān)管評(píng)估？
FDA may initiate or, in the case of a voluntary RRA, request to conduct, an RRA whenever we determine an RRA is appropriate to help fulfill the Agency’s regulatory responsibilities and to protect human and animal health. For example:
FDA 可以在確定進(jìn)行遠(yuǎn)程監(jiān)管評(píng)估是適當(dāng)?shù)那闆r下發(fā)起，或者在自愿遠(yuǎn)程監(jiān)管評(píng)估的情況下要求進(jìn)行遠(yuǎn)程監(jiān)管評(píng)估，以履行該機(jī)構(gòu)的監(jiān)管職責(zé)并保護(hù)人類和動(dòng)物健康。例如：
·When FDA cannot conduct an inspection due to travel limitations brought on by public health emergencies, natural disasters, or other situations making travel infeasible.·當(dāng) FDA 因公共衛(wèi)生緊急情況、自然災(zāi)害或其他使出行不可行的情況導(dǎo)致的出行限制而無(wú)法進(jìn)行檢查時(shí)。
·When FDA determines that an RRA will assist us in conducting elements of establishment oversight or support regulatory decisions. Examples include preparing for an already planned inspection, following up on a consumer complaint, assisting in verifying that an establishment has completed certain corrective actions (e.g., in response to a previous inspection, or previous RRA), or supporting the review of a marketing submission.當(dāng)美國(guó)食品藥品監(jiān)督管理局（FDA）確定遠(yuǎn)程監(jiān)管評(píng)估（RRA）將有助于我們開展對(duì)企業(yè)的監(jiān)管工作或支持監(jiān)管決策時(shí)。例如為已計(jì)劃好的檢查做準(zhǔn)備、跟進(jìn)消費(fèi)者投訴、協(xié)助核實(shí)企業(yè)已完成某些糾正措施（例如，針對(duì)之前的檢查或之前的遠(yuǎn)程監(jiān)管評(píng)估），或支持對(duì)上市申報(bào)材料的審查。
FDA intends to use a risk-based approach to determine whether to initiate or request an RRA. Factors that may be considered include, but are not limited to, establishment location, inspection history, complexity of product and process, and travel restrictions. Programs and centers within FDA may assess risk in the context of a potential RRA differently based on those and other factors.
美國(guó)食品藥品監(jiān)督管理局（FDA）打算采用基于風(fēng)險(xiǎn)的方法來(lái)決定是否發(fā)起或要求進(jìn)行遠(yuǎn)程監(jiān)管評(píng)估（RRA）?？赡芸紤]的因素包括但不限于企業(yè)所在地、檢查歷史、產(chǎn)品和生產(chǎn)流程的復(fù)雜程度以及出行限制。FDA 內(nèi)部的項(xiàng)目和中心可能會(huì)根據(jù)上述及其他因素，以不同方式評(píng)估潛在遠(yuǎn)程監(jiān)管評(píng)估中的風(fēng)險(xiǎn)。
The above examples are illustrative, and the ultimate decision to initiate or request an RRA rests with FDA, as we retain discretion to use RRAs as appropriate. FDA does not accept requests to perform an RRA. When FDA determines an inspection (as opposed to an RRA) is necessary, FDA intends to perform an inspection.
以上示例僅作說(shuō)明之用，最終是否發(fā)起或要求進(jìn)行遠(yuǎn)程監(jiān)管評(píng)估（RRA）的決定權(quán)在 FDA，因?yàn)槲覀儽Ａ粼谶m當(dāng)情況下使用 RRA 的自由裁量權(quán)。FDA 不接受進(jìn)行 RRA 的請(qǐng)求。當(dāng) FDA 判定有必要進(jìn)行檢查（而非 RRA）時(shí)，F(xiàn)DA 打算進(jìn)行檢查。
6.Will FDA use RRAs during or as part of an FDA inspection of an establishment?
6.美國(guó)食品藥品監(jiān)督管理局（FDA）在對(duì)企業(yè)進(jìn)行檢查期間，會(huì)將遠(yuǎn)程監(jiān)管評(píng)估（RRA）作為檢查的一部分來(lái)使用嗎
No, FDA does not plan to conduct RRAs and inspections17 of an establishment under sections 704(a)(1) or 704(a)(5) of the FD&C Act18 simultaneously. An RRA is conducted remotely by FDA staff, without FDA staff present at an establishment conducting an inspection. However, an RRA could precede, prompt, or be a follow-up to, an inspection. When an RRA precedes an inspection, FDA will generally conclude the RRA prior to initiating the inspection. FDA may combine any information gained from the RRA with any resulting observations from the subsequent inspection. In such circumstances, FDA would confirm any observations from the RRA during the subsequent inspection before including them on any Form FDA 483, Inspectional Observations, issued at the conclusion of the subsequent inspection.
不，美國(guó)食品藥品監(jiān)督管理局（FDA）不計(jì)劃同時(shí)根據(jù)《聯(lián)邦食品、藥品和化妝品法案》（FD&C Act）第 704 (a)(1) 或 704 (a)(5) 節(jié)對(duì)企業(yè)進(jìn)行遠(yuǎn)程監(jiān)管評(píng)估（RRA）和檢查。RRA 由 FDA 工作人員遠(yuǎn)程進(jìn)行，F(xiàn)DA 工作人員無(wú)需親自到企業(yè)現(xiàn)場(chǎng)開展檢查。不過(guò)，RRA 可能在檢查之前進(jìn)行、促成檢查或作為檢查的后續(xù)行動(dòng)。當(dāng) RRA 在檢查之前進(jìn)行時(shí)，F(xiàn)DA 通常會(huì)在啟動(dòng)檢查前完成該 RRA。FDA 可能會(huì)將從 RRA 中獲得的任何信息與后續(xù)檢查中產(chǎn)生的任何觀察結(jié)果結(jié)合起來(lái)。在這種情況下，F(xiàn)DA 會(huì)在后續(xù)檢查結(jié)束時(shí)發(fā)布的任何《FDA 483 表格：檢查觀察結(jié)果》中納入 RRA 的觀察結(jié)果之前，在后續(xù)檢查中確認(rèn)這些觀察結(jié)果。
Additionally, FDA may conduct an RRA following an inspection to conduct follow-up activities with the establishment or to assist in verifying corrective actions, if appropriate.
此外，美國(guó)食品藥品監(jiān)督管理局（FDA）可能在檢查后開展遠(yuǎn)程監(jiān)管評(píng)估（RRA），以與企業(yè)進(jìn)行后續(xù)活動(dòng)或在適當(dāng)情況下協(xié)助核實(shí)糾正措施。
FDA may seek to conduct an RRA (e.g., livestreaming) during oversight activities independently conducted by state or foreign regulatory partners.
美國(guó)食品藥品監(jiān)督管理局（FDA）可能會(huì)在州或外國(guó)監(jiān)管合作伙伴獨(dú)立開展的監(jiān)管活動(dòng)期間，尋求進(jìn)行遠(yuǎn)程監(jiān)管評(píng)估（RRA，例如直播）。
7.What are the benefits of an RRA?
7.遠(yuǎn)程監(jiān)管評(píng)估（RRA）的好處有哪些？
FDA, industry, and the public can all benefit from RRAs as RRAs help the Agency to meet critical public health needs. These potential benefits may include, but are not limited to:
·美國(guó)食品藥品監(jiān)督管理局（FDA）、行業(yè)和公眾均可從遠(yuǎn)程監(jiān)管評(píng)估（RRA）中受益，因?yàn)?RRA 有助于該機(jī)構(gòu)滿足關(guān)鍵的公共衛(wèi)生需求。這些潛在益處可能包括但不限于：
Allowing FDA to remotely evaluate compliance of FDA-regulated products, clinical studies, and establishments, as appropriate. This may identify issues that lead establishments to promptly make corrective actions, which in addition to addressing such issues, may enhance the establishment’s preparedness for their next FDA inspection.·允許美國(guó)食品藥品監(jiān)督管理局（FDA）在適當(dāng)情況下遠(yuǎn)程評(píng)估受其監(jiān)管的產(chǎn)品、臨床研究和企業(yè)的合規(guī)性。這可能發(fā)現(xiàn)促使企業(yè)及時(shí)采取糾正措施的問(wèn)題，除解決這些問(wèn)題外，還可能增強(qiáng)企業(yè)對(duì)下一次 FDA 檢查的準(zhǔn)備。
·Reducing resource expenditure. For example, when an RRA precedes an inspection under section 704(a) of the FD&C Act, FDA may not need to review as many records during the inspection, reducing the time FDA is present at the establishment.·減少資源支出。例如，當(dāng)遠(yuǎn)程監(jiān)管評(píng)估（RRA）先于《聯(lián)邦食品、藥品和化妝品法案》（FD&C Act）第 704 (a) 節(jié)規(guī)定的檢查進(jìn)行時(shí)，F(xiàn)DA 可能無(wú)需在檢查期間審查過(guò)多記錄，從而縮短 FDA 駐留企業(yè)的時(shí)間。
·Helping to support timely regulatory decisions (including the approval of an application or authorization for emergency use), without an inspection, when appropriate conditions are fulfilled, such as the ability to verify information in the marketing submission through use of an RRA. In such cases, the application approval, or the authorization, must still meet applicable standards.·在適當(dāng)條件滿足時(shí)（例如能夠通過(guò)遠(yuǎn)程監(jiān)管評(píng)估（RRA）核實(shí)上市申報(bào)材料中的信息），幫助支持無(wú)需進(jìn)行檢查即可及時(shí)做出監(jiān)管決策（包括批準(zhǔn)申請(qǐng)或緊急使用授權(quán)）。在此類情況下，申請(qǐng)批準(zhǔn)或授權(quán)仍必須符合適用標(biāo)準(zhǔn)。
·Providing FDA additional information to incorporate into a risk-based inspection schedule, thereby helping FDA use inspectional resources more efficiently and effectively.·為美國(guó)食品藥品監(jiān)督管理局（FDA）提供額外信息以納入基于風(fēng)險(xiǎn)的檢查計(jì)劃，從而幫助 FDA 更高效且有效地利用檢查資源。協(xié)助美國(guó)食品藥品監(jiān)督管理局（FDA）核實(shí)糾正措施。
·Assisting FDA in verifying corrective actions.·協(xié)助美國(guó)食品藥品監(jiān)督管理局（FDA）核實(shí)糾正措施。
B.Remote Regulatory Assessment Expectations
B.遠(yuǎn)程監(jiān)管評(píng)估要求
8.How may FDA request an RRA?
8.美國(guó)食品藥品監(jiān)督管理局（FDA）如何請(qǐng)求進(jìn)行遠(yuǎn)程監(jiān)管評(píng)估（RRA）？
FDA generally intends to use the following processes for requesting voluntary or initiating mandatory RRAs.
美國(guó)食品藥品監(jiān)督管理局（FDA）通常打算采用以下流程來(lái)請(qǐng)求自愿性或發(fā)起強(qiáng)制性遠(yuǎn)程監(jiān)管評(píng)估（RRA）。
FDA’s request will state whether the RRA is mandatory or voluntary (and in the case of a mandatory RRA, the authorities under which it is being requested).
FDA 的請(qǐng)求將說(shuō)明遠(yuǎn)程監(jiān)管評(píng)估（RRA）是強(qiáng)制性還是自愿性的（如為強(qiáng)制性 RRA，還會(huì)說(shuō)明提出請(qǐng)求所依據(jù)的授權(quán)）。
·In general, for voluntary RRAs
·一般而言，對(duì)于自愿性遠(yuǎn)程監(jiān)管評(píng)估（RRA）
oFDA expects to contact an establishment through the establishment’s point of contact,22 by email or phone, once we determine a voluntary RRA is appropriate.
o一般來(lái)說(shuō)，對(duì)于自愿性遠(yuǎn)程監(jiān)管評(píng)估（RRA），美國(guó)食品藥品監(jiān)督管理局（FDA）預(yù)計(jì)在確定適合開展自愿性 RRA 后，通過(guò)企業(yè)的聯(lián)系人以電子郵件或電話方式與企業(yè)取得聯(lián)系。
oFDA may use the establishment’s registration, establishment information provided in a marketing submission, or additional information available to FDA, to identify the point of contact, authorized official, or U.S. agent.
o美國(guó)食品藥品監(jiān)督管理局（FDA）可能會(huì)利用企業(yè)的注冊(cè)信息、上市申報(bào)材料中提供的企業(yè)信息，或 FDA 可獲得的其他信息，來(lái)確定聯(lián)系人、授權(quán)官員或美國(guó)代理人。
oFDA will obtain the establishment’s consent to the voluntary RRA before we begin the RRA. Where practicable, FDA generally intends to seek to obtain such consent in writing.
o美國(guó)食品藥品監(jiān)督管理局（FDA）將在開始自愿性遠(yuǎn)程監(jiān)管評(píng)估（RRA）前獲得企業(yè)對(duì)該 RRA 的同意。在可行的情況下，F(xiàn)DA 通常會(huì)力求以書面形式獲得此類同意。
oObtaining the establishment’s consent typically includes:
o獲得企業(yè)的同意通常包括：
·notifying the establishment’s point of contact of the purpose and planned scope of the RRA and of the right to refuse consent; and
·通知企業(yè)聯(lián)系人遠(yuǎn)程監(jiān)管評(píng)估（RRA）的目的和計(jì)劃范圍，以及拒絕同意的權(quán)利；
·requesting that such person confirm that the establishment voluntarily consents and has the ability to participate in the voluntary RRA requested.
·要求該人員確認(rèn)企業(yè)自愿同意并具備參與所請(qǐng)求的自愿性遠(yuǎn)程監(jiān)管評(píng)估（RRA）的能力。
oAs part of the request, FDA will typically offer the establishment the opportunity to have a discussion to inform the establishment’s decision on whether to provide consent for the voluntary RRA. Such a discussion might cover considerations, as applicable and appropriate, including:
o作為請(qǐng)求的一部分，F(xiàn)DA 通常會(huì)為企業(yè)提供討論機(jī)會(huì)，以幫助企業(yè)決定是否同意自愿性 RRA。此類討論可能會(huì)在適用且適當(dāng)?shù)那闆r下涵蓋以下考量因素，包括：
·FDA’s expectations for, and any establishment limitations in participating in, the RRA.
·美國(guó)食品藥品監(jiān)督管理局（FDA）對(duì)遠(yuǎn)程監(jiān)管評(píng)估（RRA）的預(yù)期，以及企業(yè)參與 RRA 的任何限制。
·The scheduling of virtual interviews and meetings.
·虛擬訪談和會(huì)議的時(shí)間安排。
·Technological capabilities.
·技術(shù)能力。
·The process and timeline for requesting records or other information for review.
·請(qǐng)求記錄或其他信息以供審核的流程和時(shí)間安排。·
·How and when FDA will provide feedback to the establishment.
·美國(guó)食品藥品監(jiān)督管理局（FDA）將如何及何時(shí)向企業(yè)提供反饋。
·The general process and other aspects related to logistics and capabilities
·與后勤和能力相關(guān)的一般流程及其他方面。
·In general, for mandatory RRAs
·一般而言，對(duì)于強(qiáng)制性遠(yuǎn)程監(jiān)管評(píng)估（RRA）
oFDA will initiate the request in accordance with the relevant legal authority and intends to follow any established procedures.
o美國(guó)食品藥品監(jiān)督管理局（FDA）將根據(jù)相關(guān)法律授權(quán)發(fā)起請(qǐng)求，并打算遵循任何既定程序。
oThe point of contact listed in the establishment’s registration may be used as the point of contact for the RRA request.
o企業(yè)注冊(cè)中列出的聯(lián)系人可作為遠(yuǎn)程監(jiān)管評(píng)估（RRA）請(qǐng)求的聯(lián)系人。
oFDA will use Form FDA 4003 to request records or other information under section 704(a)(4) of the FD&C Act.
o美國(guó)食品藥品監(jiān)督管理局（FDA）將根據(jù)《聯(lián)邦食品、藥品和化妝品法案》（FD&C Act）第 704 (a)(4) 條的規(guī)定，使用 FDA 4003 表格來(lái)請(qǐng)求獲取記錄或其他信息。
oFor pre-approval and pre-licensing inspections, there may be situations when, in advance of the inspection, records are requested of an establishment under section 704(a)(4) of the FD&C Act related to products named in multiple applications. In these situations, FDA intends to issue one Form FDA 4003 to the establishment to cover requests for records or other information for the relevant products in the applications being assessed.
o對(duì)于上市前批準(zhǔn)和上市前許可檢查，可能存在以下情況：在檢查前，F(xiàn)DA 會(huì)根據(jù)《聯(lián)邦食品、藥品和化妝品法案》（FD&C Act）第 704 (a)(4) 條，向企業(yè)索要與多個(gè)申請(qǐng)中所列產(chǎn)品相關(guān)的記錄。在此類情況下，F(xiàn)DA 擬向該企業(yè)簽發(fā)一份 FDA 4003 表格，以涵蓋對(duì)所評(píng)估申請(qǐng)中相關(guān)產(chǎn)品的記錄或其他信息的請(qǐng)求。
oWhen making a request under section 704(a)(4) of the FD&C Act, FDA will provide a sufficient description of the records or other information requested, as well as our rationale for requesting such records or other information in advance of, or in lieu of, an inspection.
o當(dāng)美國(guó)食品藥品監(jiān)督管理局（FDA）根據(jù)《聯(lián)邦食品、藥品和化妝品法案》（FD&C Act）第 704 (a)(4) 條提出請(qǐng)求時(shí)，將充分描述所請(qǐng)求的記錄或其他信息，并說(shuō)明在檢查前請(qǐng)求此類記錄或其他信息（或以此替代檢查）的理由。
oUpon receipt of the requested records, we will provide confirmation of receipt to the establishment.
o收到所請(qǐng)求的記錄后，我們將向企業(yè)提供收到確認(rèn)。
9.What might an establishment expect to happen during an RRA?
企業(yè)在遠(yuǎn)程監(jiān)管評(píng)估（RRA）過(guò)程中可能預(yù)期會(huì)發(fā)生什么？
RRAs may entail, but are not limited to, any combination of the following, depending on the type of RRA involved:
根據(jù)所涉及的遠(yuǎn)程監(jiān)管評(píng)估（RRA）類型，其可能包括但不限于以下任何組合：
·FDA requests and reviews records and other information (this may include records or information from electronic systems, and source records from non-clinical and clinical studies).
·FDA要求并審核記錄及其他信息（這可能包括來(lái)自電子系統(tǒng)的記錄或信息，以及非臨床和臨床研究的原始記錄）。
·Virtual meetings between FDA and responsible establishment personnel to review, where appropriate, the information provided to FDA, the establishment’s electronic systems, the establishment’s operations, and/or the establishment’s standard operating procedures. Interactions beyond the virtual meetings between FDA and an establishment may continue throughout an RRA.
·FDA與企業(yè)負(fù)責(zé)人員舉行線上會(huì)議，在適當(dāng)情況下審查向FDA提供的信息、企業(yè)的電子系統(tǒng)、運(yùn)營(yíng)情況及/或標(biāo)準(zhǔn)操作規(guī)程。FDA與企業(yè)在線上會(huì)議之外的互動(dòng)可能貫穿整個(gè)遠(yuǎn)程監(jiān)管評(píng)估（RRA）過(guò)程。
·Use of livestream and/or pre-recorded video, where appropriate, to examine facilities, operations, data, and other information.
·在適當(dāng)情況下，使用直播和/或預(yù)錄視頻檢查設(shè)施、操作、數(shù)據(jù)及其他信息。
FDA may review electronic systems and source records, including by screen sharing and livestream/video.27 FDA may provide updates to the establishment on observations and outstanding issues, whenever feasible, throughout the RRA. FDA expects to make reasonable and appropriate efforts to discuss observations with the management of the establishment, to minimize surprises, errors, and misunderstandings.- FDA可通過(guò)屏幕共享和直播/視頻等方式審核電子系統(tǒng)及原始記錄。在整個(gè)遠(yuǎn)程監(jiān)管評(píng)估（RRA）過(guò)程中，F(xiàn)DA會(huì)在可行時(shí)向企業(yè)更新檢查發(fā)現(xiàn)和未決問(wèn)題。FDA將采取合理適當(dāng)?shù)拇胧┡c企業(yè)管理層討論檢查發(fā)現(xiàn)，以最大程度減少意外、錯(cuò)誤和誤解。
While mandatory RRAs that are conducted under relevant legal authorities involve activities detailed by such authorities, an establishment required pursuant to such authorities to participate in a mandatory RRA could agree to participate in activities beyond what is required. For instance, FDA may request that an establishment subject to a records request under section 704(a)(4) of the FD&C Act instead voluntarily participate in an RRA that accommodates review through interactive technologies such as video streaming.盡管根據(jù)相關(guān)法律授權(quán)開展的強(qiáng)制性遠(yuǎn)程監(jiān)管評(píng)估（RRA）包含此類授權(quán)所詳細(xì)規(guī)定的活動(dòng)，但被該授權(quán)要求參與強(qiáng)制性 RRA 的企業(yè)可同意參與超出規(guī)定要求的活動(dòng)。例如，F(xiàn)DA 可能會(huì)要求某企業(yè)（其記錄請(qǐng)求依據(jù)《聯(lián)邦食品、藥品和化妝品法案》第 704 (a)(4) 條）自愿參與 RRA，通過(guò)視頻流等互動(dòng)技術(shù)配合審核。
10.Are there any consequences for declining to participate in an RRA?10. 拒絕參與遠(yuǎn)程監(jiān)管評(píng)估（RRA）會(huì)有什么后果嗎？
·Voluntary RRAs
·自愿性遠(yuǎn)程監(jiān)管評(píng)估（RRA）
Because of the voluntary nature of these assessments, FDA will not take enforcement action solely based on an establishment declining a voluntary RRA.28 FDA may consider other activities necessary to exercise our oversight responsibilities regarding that establishment, such as an inspection, based on considerations such as when the establishment was last inspected, our assessment of risks, and other relevant factors. An establishment may decline to participate in a voluntary RRA, but an establishment may not opt out of an FDA inspection.
由于這些評(píng)估的自愿性質(zhì)，F(xiàn)DA 不會(huì)僅因企業(yè)拒絕自愿性遠(yuǎn)程監(jiān)管評(píng)估（RRA）而采取執(zhí)法行動(dòng)。FDA 可能會(huì)基于企業(yè)上次檢查時(shí)間、風(fēng)險(xiǎn)評(píng)估及其他相關(guān)因素，考慮采取其他必要的監(jiān)管措施（如 inspections 檢查）來(lái)履行對(duì)該企業(yè)的監(jiān)督職責(zé)。企業(yè)可拒絕參與自愿性 RRA，但不得拒絕 FDA 的檢查。
However, if an establishment declines to participate in a voluntary RRA, FDA may not be able to assess the establishment’s activities until we exercise other oversight tools. Indeed, a voluntary RRA may be the most expedient means for FDA to assess the establishment, especially when factors prevent FDA from conducting a timely inspection. For example, in circumstances which temporarily limit FDA’s ability to conduct an inspection, such as travel restrictions, it may take FDA longer to assess an establishment or, for example, a marketing submission in which an establishment is referenced, absent an RRA, because we lack necessary information.
然而，若企業(yè)拒絕參與自愿性遠(yuǎn)程監(jiān)管評(píng)估（RRA），F(xiàn)DA 可能無(wú)法評(píng)估其活動(dòng)，除非啟用其他監(jiān)管工具。事實(shí)上，自愿性 RRA 可能是 FDA 評(píng)估企業(yè)的最便捷方式，尤其是當(dāng)某些因素導(dǎo)致無(wú)法及時(shí)開展檢查時(shí)。例如，在旅行限制等暫時(shí)影響 FDA 檢查能力的情況下，若缺乏 RRA，F(xiàn)DA 可能需要更長(zhǎng)時(shí)間來(lái)評(píng)估企業(yè)，或?qū)徍松婕霸撈髽I(yè)的上市申請(qǐng)，因?yàn)槲覀內(nèi)狈Ρ匾畔ⅰ?/span>
·Mandatory RRAs
·強(qiáng)制性遠(yuǎn)程監(jiān)管評(píng)估（RRA）
FDA may consider the following actions, among others, as declining to participate in a mandatory RRA: failing to respond, withdrawing participation, or refusing to provide records, upon a request made in accordance with relevant legal authorities. There can be consequences for declining mandatory RRAs.
- FDA可將以下行為（包括但不限于）視為拒絕參與強(qiáng)制性遠(yuǎn)程監(jiān)管評(píng)估（RRA）：未響應(yīng)、退出參與，或在依據(jù)相關(guān)法律授權(quán)提出請(qǐng)求時(shí)拒絕提供記錄。拒絕強(qiáng)制性RRA可能面臨后果。
For example, an establishment that refuses a request for records or other information under section 704(a)(4) of the FD&C Act may be in violation of the FD&C Act.
例如，企業(yè)若拒絕根據(jù)《聯(lián)邦食品、藥品和化妝品法案》第704(a)(4)條提出的記錄或其他信息請(qǐng)求，可能違反該法案
Similarly, if an importer refuses FDA’s written request for FSVP records under 21 CFR 1.510(b)(3) or 1.512(b)(5)(ii)(C), the importer may be in violation of section 805 of the FD&C Act, and the food offered for import by the importer may be subject to refusal under section 801(a)(3) of the FD&C Act.
- 同樣，若進(jìn)口商拒絕FDA根據(jù)《美國(guó)聯(lián)邦法規(guī)》第21編第1.510(b)(3)或1.512(b)(5)(ii)(C)條提出的外國(guó)供應(yīng)商驗(yàn)證計(jì)劃（FSVP）記錄書面請(qǐng)求，可能違反《聯(lián)邦食品、藥品和化妝品法案》第805條，且該進(jìn)口商申報(bào)進(jìn)口的食品可能依據(jù)該法案第801(a)(3)條被拒絕入境。
FDA intends to take appropriate action against persons32 and products that are in violation of the FD&C Act.
- FDA 擬對(duì)違反《聯(lián)邦食品、藥品和化妝品法案》的相關(guān)人員³²及產(chǎn)品采取適當(dāng)行動(dòng)。
11.Are there any technological expectations for an RRA?
11. 遠(yuǎn)程監(jiān)管評(píng)估（RRA）對(duì)技術(shù)有何要求？
The technological expectations will vary depending on the type of RRA and its scope. Certain RRAs involve records requests, and the records may be submitted electronically or through other means, as applicable. Other RRAs may require additional technological capability. For example, if FDA expects that the RRA could include the use of live streaming video, FDA may inquire about hardware or internet connectivity to assess IT operability, security, and privacy controls to protect the confidentiality of the data. The quality of the remote connection (e.g., connectivity, image quality, cameras used) should be adequate for FDA to review, observe, examine, and evaluate the requested records, documents, and other information (including electronic systems). To the extent practicable, technologies employed should also allow access for remotely viewing and evaluating operations at the establishment, as appropriate (e.g., aseptic practices, equipment cleaning and set up, material weighing and dispensing, instrument set up, sampling, and testing).
技術(shù)要求將因遠(yuǎn)程監(jiān)管評(píng)估（RRA）的類型和范圍而異。某些 RRA 涉及記錄請(qǐng)求，記錄可根據(jù)適用情況以電子方式或其他手段提交。其他 RRA 可能需要額外技術(shù)能力。例如，若 FDA 預(yù)期 RRA 可能包含直播視頻使用，將詢問(wèn)硬件或網(wǎng)絡(luò)連接情況，以評(píng)估信息技術(shù)的可操作性、安全性及隱私控制措施，從而保護(hù)數(shù)據(jù)機(jī)密性。遠(yuǎn)程連接質(zhì)量（如連接穩(wěn)定性、圖像清晰度、所用攝像頭等）應(yīng)足以支持 FDA 審查、觀察、檢查和評(píng)估所需記錄、文件及其他信息（包括電子系統(tǒng)）。在可行范圍內(nèi)，所采用的技術(shù)還應(yīng)允許適當(dāng)遠(yuǎn)程查看和評(píng)估企業(yè)操作（如無(wú)菌操作、設(shè)備清潔與調(diào)試、物料稱量與分配、儀器架設(shè)、采樣及檢測(cè)等）。
If an establishment is unable to support streaming video or other live virtual interactions, or if FDA determines that the streaming video or any other virtual interaction during the RRA does not permit a sufficient examination of the establishment or of a corrective action, FDA may use other available tools or may terminate the RRA and consider other actions necessary to exercise our oversight responsibilities regarding that establishment, such as an inspection.
- 若企業(yè)無(wú)法支持視頻直播或其他實(shí)時(shí)線上互動(dòng)，或FDA判定在遠(yuǎn)程監(jiān)管評(píng)估（RRA）過(guò)程中通過(guò)視頻直播或其他線上互動(dòng)無(wú)法充分檢查企業(yè)情況或糾正措施，F(xiàn)DA可能會(huì)使用其他可用工具，或終止RRA并考慮采取其他必要行動(dòng)以履行對(duì)該企業(yè)的監(jiān)管職責(zé)（如開展檢查）。
Recommendations for sending records or other information are further explained in Question 15, below.
- 關(guān)于提交記錄或其他信息的建議將在下文第15問(wèn)中進(jìn)一步說(shuō)明。
C.Requests for Records or Other Information as Part of Remote Regulatory Assessments
C. 作為遠(yuǎn)程監(jiān)管評(píng)估（RRA）一部分的記錄或其他信息請(qǐng)求
12.What records or other information may FDA request as part of an RRA?
12. 作為遠(yuǎn)程監(jiān)管評(píng)估（RRA）的一部分，F(xiàn)DA可能請(qǐng)求哪些記錄或其他信息？
For voluntary RRAs, FDA may request records or other information appropriate to determine whether an establishment or FDA-regulated product is in compliance with applicable requirements. The records and other information will typically be similar to what FDA would request during an inspection under section 704(a)(1) of the FD&C Act.
- 對(duì)于自愿性遠(yuǎn)程監(jiān)管評(píng)估（RRA），F(xiàn)DA可能會(huì)請(qǐng)求適當(dāng)?shù)挠涗浕蚱渌畔?，以確定某企業(yè)或FDA監(jiān)管的產(chǎn)品是否符合適用要求。這些記錄和其他信息通常與FDA根據(jù)《聯(lián)邦食品、藥品和化妝品法案》第704(a)(1)條開展檢查時(shí)可能請(qǐng)求的內(nèi)容類似。
In the case of mandatory RRAs, the records or other information we request, and the circumstances under which we request them, will conform to the relevant legal authority. For example, under section 704(a)(4) of the FD&C Act, FDA may request any records or other information subject to inspection under section 704 of the FD&C Act. For mandatory RRAs under 21 CFR 1.510(b)(3) and 1.512(b)(5)(ii)(C), FDA may request any and all records that are required to be maintained under 21 CFR Part 1, Subpart L.
- 對(duì)于強(qiáng)制性遠(yuǎn)程監(jiān)管評(píng)估（RRA），我們所請(qǐng)求的記錄或其他信息及其請(qǐng)求的情形，將符合相關(guān)法律授權(quán)。例如，根據(jù)《聯(lián)邦食品、藥品和化妝品法案》第704(a)(4)條，F(xiàn)DA可請(qǐng)求《聯(lián)邦食品、藥品和化妝品法案》第704條規(guī)定的任何可接受檢查的記錄或其他信息。 - 對(duì)于依據(jù)《美國(guó)聯(lián)邦法規(guī)》第21編第1.510(b)(3)和1.512(b)(5)(ii)(C)條開展的強(qiáng)制性RRA，F(xiàn)DA可請(qǐng)求《美國(guó)聯(lián)邦法規(guī)》第21編第1部分L子部分要求保存的任何及所有記錄。
Examples of records or other information the Agency may request during a voluntary or mandatory RRA may include, but are not limited to:
- FDA在自愿性或強(qiáng)制性遠(yuǎn)程監(jiān)管評(píng)估（RRA）中可能請(qǐng)求的記錄或其他信息示例包括但不限于：
·Records of specific production lots or batches as well as product-specific information, such as periodic product reviews, product quality reports, equipment records, process validation records and reports, test results, records of product postmarket defects, or other information related to compliance with Current Good Manufacturing Practice requirements.
·特定生產(chǎn)批次記錄及產(chǎn)品相關(guān)信息，例如定期產(chǎn)品審核、產(chǎn)品質(zhì)量報(bào)告、設(shè)備記錄、工藝驗(yàn)證記錄與報(bào)告、檢測(cè)結(jié)果、產(chǎn)品上市后缺陷記錄，或其他與符合現(xiàn)行良好生產(chǎn)規(guī)范（CGMP）要求相關(guān)的信息。
·Certain summary records or lists of records, such as a summary of batches manufactured and their disposition, or a summary of discrepancies and investigations related to manufacturing and testing.
·特定匯總記錄或記錄清單，例如已生產(chǎn)批次及其處理情況的匯總，或與生產(chǎn)和檢測(cè)相關(guān)的偏差及調(diào)查匯總。
·Read-only access to electronic databases or a request that an establishment walk us through information in their database or provide data queries or summary data generated by the establishment from their databases.
·電子數(shù)據(jù)庫(kù)的只讀訪問(wèn)權(quán)限，或要求企業(yè)引導(dǎo)我們查看其數(shù)據(jù)庫(kù)中的信息，或提供企業(yè)從數(shù)據(jù)庫(kù)生成的數(shù)據(jù)查詢結(jié)果或匯總數(shù)據(jù)。
·Standard Operating Procedures and records generated by the establishment to document control of quality systems and/or to demonstrate compliance with FDA requirements.
·企業(yè)制定的標(biāo)準(zhǔn)操作程序（SOP）及相關(guān)記錄，用于記錄質(zhì)量體系控制情況和/或證明符合FDA要求。
·For FSVP importers, records related to hazard analysis, the importer’s determination of appropriate supplier verification activities, performance of supplier verification activities, and/or corrective actions.
·對(duì)于外國(guó)供應(yīng)商驗(yàn)證計(jì)劃（FSVP）進(jìn)口商，相關(guān)記錄包括危害分析、進(jìn)口商對(duì)適當(dāng)供應(yīng)商驗(yàn)證活動(dòng)的判定、供應(yīng)商驗(yàn)證活動(dòng)的執(zhí)行情況，及/或糾正措施記錄。
·For establishments subject to BIMO inspection, records or data related to the reporting or conduct of FDA-regulated research.
·對(duì)于需接受生物研究監(jiān)控（BIMO）檢查的企業(yè)，與FDA監(jiān)管研究的報(bào)告或?qū)嵤┫嚓P(guān)的記錄或數(shù)據(jù)。
Where applicable, FDA intends to take appropriate efforts to minimize the quantity of records or other information requested and may request that establishments take reasonable efforts to facilitate and expedite FDA’s collection and review of records. See Questions 14 and 15 for additional details.
在適用情況下，F(xiàn)DA擬采取適當(dāng)措施盡量減少所請(qǐng)求記錄或其他信息的數(shù)量，并可能要求企業(yè)合理協(xié)助以加快FDA對(duì)記錄的收集和審核。更多詳情見第14問(wèn)和第15問(wèn)。
13.For what purposes may FDA use the records and other information gathered during an RRA?
13.FDA可將遠(yuǎn)程監(jiān)管評(píng)估（RRA）過(guò)程中收集的記錄和其他信息用于哪些目的？
Depending on the scope of the RRA, the records and other information may be used by FDA for, among other things,35 the following purposes:
根據(jù)遠(yuǎn)程監(jiān)管評(píng)估（RRA）的范圍，F(xiàn)DA可將記錄和其他信息用于以下目的（包括但不限于）：
·Support FDA’s assessment of pending marketing submissions, including whether to approve an application or whether to issue a response, such as a complete response letter.
·支持FDA對(duì)待審上市申報(bào)資料的評(píng)估，包括決定是否批準(zhǔn)申請(qǐng)或是否發(fā)出回復(fù)（如完整回復(fù)函）。
·Determine whether an establishment or product is or is not in compliance with certain FD&C Act or Public Health Service Act requirements, and other applicable requirements.
·判定某企業(yè)或產(chǎn)品是否符合《聯(lián)邦食品、藥品和化妝品法案》《公共衛(wèi)生服務(wù)法案》的特定要求及其他適用要求。
·Facilitate assessment of the need for an inspection in follow-up to a reported concern or defect.
·協(xié)助評(píng)估針對(duì)所報(bào)告問(wèn)題或缺陷開展后續(xù)檢查的必要性。
·Support actions such as a regulatory meeting, warning letter, import action, recall activity, or other advisory action, or to support an administrative or judicial action.
·支持監(jiān)管會(huì)議、警告信、進(jìn)口措施、召回行動(dòng)或其他咨詢行動(dòng)等舉措，或?yàn)樾姓蛩痉ㄐ袆?dòng)提供支持。
·Determine the priority of establishments for inspection, particularly a surveillance inspection.
·確定企業(yè)的檢查優(yōu)先級(jí)，尤其是監(jiān)督檢查的優(yōu)先級(jí)。
14.If the RRA requests records or other information, what is the timeframe for submitting the records and other information to FDA?
14. 若遠(yuǎn)程監(jiān)管評(píng)估（RRA）要求提供記錄或其他信息，向FDA提交這些記錄和信息的時(shí)間框架是怎樣的？
For mandatory RRAs, FDA will request that records and other information be submitted within a timeframe consistent with the relevant legal authority.37 For voluntary RRAs, FDA may suggest timeframes to ensure the RRA is completed in a reasonable amount of time and expects establishments to work diligently to provide the requested records and other information. If necessary, establishments should communicate to the FDA point of contact as soon as possible if there is a need for an extension.The circumstances that relate to FDA’s expectations for reasonable request timeframes may include:
對(duì)于強(qiáng)制性遠(yuǎn)程監(jiān)管評(píng)估（RRA），F(xiàn)DA會(huì)要求在符合相關(guān)法律授權(quán)的時(shí)間框架內(nèi)提交記錄和其他信息。對(duì)于自愿性RRA，F(xiàn)DA可能會(huì)建議時(shí)間框架以確保在合理時(shí)間內(nèi)完成RRA，并期望企業(yè)積極努力提供所請(qǐng)求的記錄和其他信息。如有必要，若企業(yè)需要延期，應(yīng)盡快與FDA聯(lián)系人溝通。與FDA對(duì)合理請(qǐng)求時(shí)間框架的預(yù)期相關(guān)的情形可能包括：
·The size, available resources, and capabilities of the establishment, including those that might exist for small businesses.
·企業(yè)的規(guī)模、可用資源及能力，包括小企業(yè)可能具備的資源與能力。
·The type, complexity, and volume of the records and other information being requested.
·所請(qǐng)求記錄及其他信息的類型、復(fù)雜程度和數(shù)量。
·The reason for the request, such as an application action goal date, deadline, or other time- sensitive reasons.
·請(qǐng)求的原因，例如申請(qǐng)行動(dòng)目標(biāo)日期、截止期限或其他有時(shí)效性的原因。
·Need for translation of records.
·記錄翻譯的需求。
15.How should records or other information in response to an RRA request be provided to FDA?
15. 針對(duì)遠(yuǎn)程監(jiān)管評(píng)估（RRA）請(qǐng)求的記錄或其他信息應(yīng)如何提供給FDA？
Except as provided below, requested records or other information generally should be submitted in an electronic format. FDA intends to identify and use a secure means to send requested records and information. For electronic documents, establishments should identify any limitations on external access and ensure that encrypted and password-protected files can be accessed by FDA. FDA will follow federal laws and regulations governing the confidentiality and retention of records and information submitted to the Agency (see, e.g., 5 U.S.C. 552(b)(4), and 18 U.S.C. 1905, 21 CFR Part 20).
除非另有規(guī)定，所請(qǐng)求的記錄或其他信息通常應(yīng)以電子格式提交。FDA擬確定并使用安全方式發(fā)送所請(qǐng)求的記錄和信息。對(duì)于電子文檔，企業(yè)應(yīng)注明外部訪問(wèn)限制，并確保FDA可訪問(wèn)加密和受密碼保護(hù)的文件。FDA將遵循管理提交至該機(jī)構(gòu)的記錄和信息的保密性及保存的聯(lián)邦法律法規(guī)（例如，參見《美國(guó)法典》第5編第552條(b)(4)款、第18編第1905條，以及《聯(lián)邦法規(guī)匯編》第21編第20部分）。
FDA recognizes that some establishments maintain documents in paper format. Requested documents maintained in paper format should be scanned as searchable Portable Document Format (PDF) files, when possible, and sent by the secure means identified by FDA. If a paper format is the only option for sending copies of records, FDA will provide the name and contact information of the FDA staff member to whom the records should be sent.
FDA認(rèn)識(shí)到部分企業(yè)以紙質(zhì)形式保存文件。對(duì)于以紙質(zhì)形式保存的被請(qǐng)求文件，應(yīng)盡可能掃描為可檢索的PDF（便攜式文檔格式）文件，并通過(guò)FDA指定的安全方式發(fā)送。如果只能以紙質(zhì)形式發(fā)送記錄副本，F(xiàn)DA將提供接收記錄的FDA工作人員姓名及聯(lián)系方式。
FDA may request that records and other information submitted to FDA be in English or accompanied by an English translation. If translated, there should be a verification that the translation is complete and accurate, and, when applicable, should include the name, address, and a brief statement of the qualifications of the translator. Copies of the original records and information should also be included in the response, where appropriate. For certain RRAs, if a verified39 translation is not immediately available, FDA may request that the initial translation be followed up with a verified translation as soon as practicable.
FDA可能要求提交至該機(jī)構(gòu)的記錄及其他信息為英文或附英文翻譯件。若提供翻譯件，需驗(yàn)證翻譯內(nèi)容完整準(zhǔn)確，適當(dāng)時(shí)應(yīng)包含翻譯人員的姓名、地址及資質(zhì)簡(jiǎn)要說(shuō)明。必要時(shí)，回復(fù)中還應(yīng)附上原始記錄和信息的副本。對(duì)于特定遠(yuǎn)程監(jiān)管評(píng)估（RRA），若無(wú)法立即提供經(jīng)核實(shí)的翻譯件，F(xiàn)DA可能要求在初步翻譯后盡快補(bǔ)充經(jīng)核實(shí)的翻譯件。
If the records or other information are provided as part of a request under section 704(a)(4) of the FD&C Act, the records and information may be submitted in either electronic or physical form. FDA will provide confirmation upon receipt of the records.40 In general, FDA intends to maintain open communications to discuss any records received over the course of the RRA.
若記錄或其他信息是根據(jù)《聯(lián)邦食品、藥品和化妝品法案》第704(a)(4)條的要求提供，這些記錄和信息可通過(guò)電子或紙質(zhì)形式提交。FDA收到記錄后將予以確認(rèn)?？傮w而言，F(xiàn)DA擬保持溝通渠道暢通，以討論在遠(yuǎn)程監(jiān)管評(píng)估（RRA）過(guò)程中收到的任何記錄。
For RRAs under 21 CFR 1.510(b)(3) and 1.512(b)(5)(ii)(C), records must be sent electronically, or through any other means that delivers the records promptly upon written request from FDA.
- 對(duì)于《聯(lián)邦法規(guī)匯編》第21編第1.510(b)(3)條和第1.512(b)(5)(ii)(C)條規(guī)定的遠(yuǎn)程監(jiān)管評(píng)估（RRA），記錄必須以電子形式發(fā)送，或通過(guò)FDA書面請(qǐng)求中指定的任何其他能及時(shí)送達(dá)記錄的方式提交。
D.Completion of a Remote Regulatory Assessment
D. 遠(yuǎn)程監(jiān)管評(píng)估的完成
16.What may occur upon completion of an RRA?
16. 遠(yuǎn)程監(jiān)管評(píng)估（RRA）完成后可能會(huì)發(fā)生什么？
Upon completion of an RRA, FDA may have a closeout meeting41 with the establishment’s management. At the closeout meeting, FDA may present a written list of RRA observations, if any, and describe and discuss such observations in sufficient detail to enable understanding and foster an appropriate response. For purposes of this guidance, RRA observations are defined as conditions and/or practices observed during the RRA that indicate, in the judgment of the FDA employee(s) conducting the RRA, a potential violation of the laws enforced by FDA. FDA does not intend to issue a Form FDA 483, Inspectional Observations, for an RRA. (See Question 6 for a discussion of how observations from an RRA may be confirmed during an inspection and included on a Form 483).
- 遠(yuǎn)程監(jiān)管評(píng)估（RRA）完成后，F(xiàn)DA可能會(huì)與企業(yè)管理層召開結(jié)案會(huì)議?¹。在結(jié)案會(huì)議上，F(xiàn)DA可能會(huì)提供一份書面的RRA觀察結(jié)果清單（如有），并對(duì)這些觀察結(jié)果進(jìn)行充分詳細(xì)的描述和討論，以確保理解并促進(jìn)適當(dāng)回應(yīng)。在本指南中，RRA觀察結(jié)果的定義為：在RRA過(guò)程中觀察到的條件和/或?qū)嵺`，經(jīng)開展RRA的FDA工作人員判斷，表明可能違反FDA執(zhí)行的法律。FDA不打算為RRA簽發(fā)FDA 483表格（檢查觀察結(jié)果）。（有關(guān)RRA觀察結(jié)果如何在檢查中確認(rèn)并列入483表格的討論，見問(wèn)題6）。
An establishment should be aware that a written list of RRA observations may be subject to a request under the Freedom of Information Act at the time the disclosure to the establishment is first made (see 21 CFR 20.101(a)) and may be made publicly available, with applicable redaction of information that is exempt from public disclosure (see, e.g., 5 U.S.C. 552(b), 18 U.S.C. 1905, 21 U.S.C. 331(j), 360j(c), 360nn(e), and 387f(c), and 21 CFR Part 20).
- 企業(yè)應(yīng)當(dāng)知曉，RRA觀察結(jié)果的書面清單可能在首次向企業(yè)披露時(shí)被依據(jù)《信息自由法》提出公開請(qǐng)求（參見《聯(lián)邦法規(guī)匯編》第21編第20.101(a)條），且在對(duì)依法免于公開披露的信息進(jìn)行適當(dāng) redaction（刪改）后可能向公眾公開（例如，參見《美國(guó)法典》第5編第552條(b)款、第18編第1905條、第21編第331(j)條、第360j(c)條、第360nn(e)條、第387f(c)條，以及《聯(lián)邦法規(guī)匯編》第21編第20部分）。
FDA encourages establishments to respond during a closeout meeting, and/or provide written responses to observations received at the closeout meeting within fifteen (15) U.S. business days. Responses or corrective actions submitted to FDA during that timeframe in response to the issues identified during the RRA generally will be considered before further Agency action or decision. Establishment responses are available for public disclosure as described in 21 CFR 20.103 with redaction of non-public information, as appropriate.
- FDA鼓勵(lì)企業(yè)在結(jié)案會(huì)議期間作出回應(yīng)，和/或在十五（15）個(gè)美國(guó)工作日內(nèi)針對(duì)結(jié)案會(huì)議中收到的觀察結(jié)果提供書面回復(fù)。在該時(shí)間框架內(nèi)就RRA期間發(fā)現(xiàn)的問(wèn)題提交給FDA的回復(fù)或糾正措施，通常會(huì)在FDA采取進(jìn)一步行動(dòng)或作出決定前得到考慮。企業(yè)回復(fù)可按《聯(lián)邦法規(guī)匯編》第21編第20.103條的規(guī)定公開披露，并對(duì)非公開信息進(jìn)行適當(dāng)刪改。
FDA’s written list of RRA observations is not a final Agency action or decision. However, information collected during an RRA may be used in support of such actions or decisions. Following an RRA, FDA may conduct an inspection or may consider other actions, as appropriate, including an enforcement action.
- FDA的RRA觀察結(jié)果書面清單并非該機(jī)構(gòu)的最終行動(dòng)或決定。然而，RRA期間收集的信息可能用于支持此類行動(dòng)或決定。在RRA之后，F(xiàn)DA可能會(huì)視情況進(jìn)行檢查或考慮其他行動(dòng)，包括執(zhí)法行動(dòng)。
As part of the RRA process, FDA intends to ordinarily prepare a report consisting of a narrative and supporting documents that summarizes information reviewed, conditions and practices found, and RRA observations identified. In general, FDA expects to provide a written copy of the narrative portion of the RRA report43 to the establishment, following the determination that the RRA is closed (see 21 CFR 20.64(d)(3)). At that time, the RRA report and its supporting documents may also be subject to public disclosure, with applicable redactions, in response to a FOIA request.
- 作為遠(yuǎn)程監(jiān)管評(píng)估（RRA）流程的一部分，F(xiàn)DA通常會(huì)準(zhǔn)備一份報(bào)告，包含敘述性內(nèi)容及支持性文件，總結(jié)所審查的信息、發(fā)現(xiàn)的條件和實(shí)踐，以及確定的RRA觀察結(jié)果。一般而言，F(xiàn)DA預(yù)計(jì)在確定RRA結(jié)案后，向企業(yè)提供RRA報(bào)告敘述部分的書面副本（參見《聯(lián)邦法規(guī)匯編》第21編第20.64(d)(3)條）。屆時(shí)，RRA報(bào)告及其支持性文件也可能在回應(yīng)《信息自由法》（FOIA）請(qǐng)求時(shí)，經(jīng)適當(dāng)刪改后予以公開披露。
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