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近(jin)日，FDA 發布了《行業(ye)指南：遠(yuan)(yuan)(yuan)程(cheng)監(jian)(jian)(jian)(jian)(jian)管(guan)(guan)評(ping)(ping)(ping)估(gu)(gu)(gu)（RRA）指南—問答(da)》，該指南將遠(yuan)(yuan)(yuan)程(cheng)監(jian)(jian)(jian)(jian)(jian)管(guan)(guan)評(ping)(ping)(ping)估(gu)(gu)(gu)（RRA）正式(shi)確立為常態(tai)化監(jian)(jian)(jian)(jian)(jian)管(guan)(guan)工具 —— 文件包(bao)含：哪些主體可能(neng)受到遠(yuan)(yuan)(yuan)程(cheng)監(jian)(jian)(jian)(jian)(jian)管(guan)(guan)評(ping)(ping)(ping)估(gu)(gu)(gu)？遠(yuan)(yuan)(yuan)程(cheng)監(jian)(jian)(jian)(jian)(jian)管(guan)(guan)評(ping)(ping)(ping)估(gu)(gu)(gu)是否正在(zai)取代其他既定的(de)(de)非檢查獲取信息的(de)(de)方式(shi)？FDA何時可能(neng)啟動或要(yao)求(qiu)進行遠(yuan)(yuan)(yuan)程(cheng)監(jian)(jian)(jian)(jian)(jian)管(guan)(guan)評(ping)(ping)(ping)估(gu)(gu)(gu)？遠(yuan)(yuan)(yuan)程(cheng)監(jian)(jian)(jian)(jian)(jian)管(guan)(guan)評(ping)(ping)(ping)估(gu)(gu)(gu)的(de)(de)要(yao)求(qiu)？企業(ye)在(zai)遠(yuan)(yuan)(yuan)程(cheng)監(jian)(jian)(jian)(jian)(jian)管(guan)(guan)評(ping)(ping)(ping)估(gu)(gu)(gu)期間可能(neng)預期會發生(sheng)什么(me)？遠(yuan)(yuan)(yuan)程(cheng)監(jian)(jian)(jian)(jian)(jian)管(guan)(guan)評(ping)(ping)(ping)估(gu)(gu)(gu)完(wan)成(cheng)后可能(neng)會發生(sheng)什么(me)？等(deng)問題的(de)(de)解答(da)：

以下為指南的原文及其翻譯
Guidance for Industry

行業指南

Conducting Remote Regulatory Assessments

開展遠程監管評估

Questions and Answers

問答

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、問答

A. Remote Regulatory Assessment FundamentalsA. 遠程(cheng)監管評估(gu)基礎

1. What is an RRA?1. 什么(me)是遠程監管評(ping)估（RRA）？

2. Who may be subject to an RRA?2. 哪些主體可能接受遠程監管評估？

3. Are RRAs replacing other established means of obtaining information outside of inspections?3. 遠程(cheng)監(jian)管評估是否正(zheng)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. 遠程監管評估是一種檢查(cha)嗎(ma)？

5. When may FDA initiate or request to conduct an RRA?5. 美(mei)國食(shi)品藥(yao)品監督管理(li)局（FDA）何時可能啟動(dong)或(huo)要求進行(xing)遠程監管評估？

6. Will FDA use RRAs during or as part of an FDA inspection of an establishment?6. FDA 在對企業(ye)進行檢(jian)查(cha)期間或作(zuo)為檢(jian)查(cha)的一部(bu)分時會使用遠程(cheng)監管評(ping)估嗎(ma)？

7. What are the benefits of an RRA?7. 遠程(cheng)監管評估的好處是什么？B. Remote Regulatory Assessment ExpectationsB. 遠程(cheng)監管評估預期(qi)

8. How may FDA request an RRA?8. FDA 如何要求進行遠程監管(guan)評估？

9. What might an establishment expect to happen during an RRA?9. 企(qi)業在遠程監(jian)管評估期間可能預期會發(fa)生什(shen)么？

10. Are there any consequences for declining to participate in an RRA?10. 拒絕參與遠程監管(guan)評(ping)估會(hui)有什么后果？

11. Are there any technological expectations for an RRA?11. 對遠程(cheng)監(jian)管(guan)評估有哪些技(ji)術方面的預期(qi)？C. Requests for Records or Other Information as Part of Remote Regulatory AssessmentsC. 作為(wei)遠程(cheng)監(jian)管(guan)評估一部分的記錄(lu)或其他信(xin)息請求

12. What records or other information may FDA request as part of an RRA?12. FDA 作(zuo)為遠程(cheng)監管評估的一部分可能(neng)會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(yong)在遠程監管評估期間收集的記(ji)錄和其他信息(xi)的目的是什么(me)？

14. If the RRA requests records or other information, what is the timeframe for submitting the records and other information to FDA?14. 如果遠程監管評(ping)估要求(qiu)提供記錄(lu)或其他信息，向(xiang) FDA 提交(jiao)這些記錄(lu)和(he)其他信息的時間框架是(shi)怎(zen)樣的？

15. How should records or other information in response to an RRA request be provided to FDA?15. 應如(ru)何向 FDA 提供對(dui)遠程監(jian)管評估(gu)請求作(zuo)出回應的記(ji)錄或其他信息(xi)？D. Completion of a Remote Regulatory AssessmentD. 遠程監(jian)管評估(gu)的完成(cheng)

16. What may occur upon completion of an RRA?16. 遠程監管(guan)評估完成后可(ke)能會發生什么？

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(ben)指南代(dai)表了FDA 對(dui)該主題的當(dang)前想法。它不會為任(ren)何人確立任(ren)何權利，對(dui) FDA 或公眾也沒有約束力。如果滿足(zu)適用法規的要求，您(nin)可以采用替代(dai)方(fang)法。若要討論替代(dai)方(fang)法，請聯系標(biao)題頁所列負(fu)責本(ben)指南的 FDA 工作人員(yuan)或辦公室(shi)。

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(wei)應對 2019 冠狀病毒病（COVID - 19）大流(liu)行，FDA 調(diao)整了(le)其(qi)現場活(huo)(huo)動的(de)(de)(de)操作方式，以(yi)便在(zai)減輕 COVID - 19 傳播的(de)(de)(de)同(tong)(tong)時對受(shou)監(jian)管行業(ye)進(jin)行監(jian)督。在(zai) COVID - 19 公共(gong)衛生緊急事(shi)件期(qi)間，用(yong)(yong)于監(jian)督 FDA 監(jian)管產(chan)品(pin)的(de)(de)(de)一(yi)(yi)套(tao)工具是(shi)遠(yuan)(yuan)程(cheng)(cheng)監(jian)管評(ping)估(gu)（RRAs）。“RRA” 一(yi)(yi)詞（在(zai)問答部分(fen)定(ding)(ding)(ding)義）用(yong)(yong)于描述一(yi)(yi)類活(huo)(huo)動，FDA 可能會使用(yong)(yong)不同(tong)(tong)術語(yu)來(lai)稱呼這類活(huo)(huo)動，但它們都被視(shi)為(wei) RRA 的(de)(de)(de)類型，包括 “遠(yuan)(yuan)程(cheng)(cheng)互動評(ping)估(gu)” 和 “遠(yuan)(yuan)程(cheng)(cheng)記錄審查”。就本(ben)(ben)指(zhi)(zhi)(zhi)南(nan)而(er)(er)言，此(ci)類活(huo)(huo)動以(yi)及本(ben)(ben)指(zhi)(zhi)(zhi)南(nan)中確定(ding)(ding)(ding)的(de)(de)(de)其(qi)他(ta)活(huo)(huo)動被視(shi)為(wei) RRA。在(zai) COVID - 19 大流(liu)行期(qi)間面臨旅(lv)行限制時，FDA 使用(yong)(yong) RRA 來(lai)評(ping)估(gu)企業(ye)及其(qi)對適(shi)用(yong)(yong) FDA 要求的(de)(de)(de)合規情況。基于這一(yi)(yi)經驗，美國食品(pin)藥品(pin)監(jian)督管理局（FDA）已認識到遠(yuan)(yuan)程(cheng)(cheng)監(jian)管評(ping)估(gu)（RRAs）的(de)(de)(de)價值，并(bing)得出結(jie)論：在(zai)新冠疫(yi)情之外，對于一(yi)(yi)系(xi)列 FDA 監(jian)管的(de)(de)(de)產(chan)品(pin)而(er)(er)言，RRAs 是(shi)一(yi)(yi)種有益(yi)的(de)(de)(de)監(jian)管工具。FDA 制定(ding)(ding)(ding)了(le)本(ben)(ben)指(zhi)(zhi)(zhi)南(nan)，以(yi)解答與 RRAs 相關的(de)(de)(de)常見問題。本(ben)(ben)指(zhi)(zhi)(zhi)南(nan)旨在(zai)幫助(zhu)加強行業(ye)對 RRAs 的(de)(de)(de)理解，從(cong)而(er)(er)促進(jin) FDA 開(kai)展 RRAs 的(de)(de)(de)流(liu)程(cheng)(cheng)。該指(zhi)(zhi)(zhi)南(nan)最(zui)終確定(ding)(ding)(ding)了(le) 2024 年 1 月(yue) 26 日發布的(de)(de)(de)同(tong)(tong)名(ming)修訂草案指(zhi)(zhi)(zhi)南(nan)（《聯邦(bang)公報(bao)》第 89 卷，第 5244 頁(ye)）。

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(ben)指(zhi)南中(zhong)，“FDA”、“機構”、“我們(men)”、“我們(men)的” 等術語均指(zhi)美國食品藥品監(jian)督(du)管(guan)理(li)局(ju)（Food and Drug Administration）。在本(ben)指(zhi)南中(zhong)，“企業” 一詞包括受 FDA 監(jian)管(guan)法律約束(shu)的任何場所、實體、個(ge)人、進口商或地(di)點(dian)，無論其(qi)位于國外(wai)還是(shi)國內。

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(zhi)南文件，包括本指(zhi)南，并不(bu)構成(cheng)具有法(fa)(fa)律(lv)強制(zhi)執行力的責(ze)任。相反，指(zhi)南文件描述了我們對某一主(zhu)題的當前想法(fa)(fa)，應僅被(bei)視(shi)為建(jian)議，除非引用了特(te)定(ding)的法(fa)(fa)規(gui)或法(fa)(fa)定(ding)要(yao)求。機構指(zhi)南中 “應該”（should）一詞的使(shi)用意味(wei)著某事物(wu)是被(bei)建(jian)議或推薦的，而非強制(zhi)要(yao)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 使用多種工具對受其監管的產品和企業進行監督。在新冠疫情期間，FDA 使用遠程評估（RRAs）來幫助該機構進行監督、降低風險，并滿足對某些受 FDA 監管產品的關鍵公共衛生需求。遠程評估包括：（1）根據《聯邦食品、藥品和化妝品法案》（FD&C 法案）第 704 (a)(4) 條，應 FDA 要求，某些企業提交的記錄或其他信息的強制性遠程評估；（2）根據《聯邦食品、藥品和化妝品法案》第 805 條（以下簡稱 “外國供應商驗證計劃（FSVP）記錄要求”，見 21 CFR 1.510 (b)(3) 或 1.512 (b)(5)(ii)(C)'）對食品進口商記錄的強制性審查；以及（3）涉及遠程記錄請求和 / 或互動評估（如遠程操作視頻直播、電話會議和屏幕共享）的自愿遠程評估。
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.美國食品藥品監督管理局（FDA）已確定使用遠程評估（RRAs）具有顯著益處。例如，遠程評估協助 FDA 核實先前合規的制造商針對檢查所采取的糾正措施，并在實地檢查不可行時獲取合規情況的見解。遠程評估還提供了有關缺陷做法的信息，促使 FDA 采取監管行動和 / 或進行檢查，同時也為未來的檢查規劃提供信息。遠程評估被用于支持審查并促進及時改進或糾正營銷宣傳聲明。在食品計劃中，遠程評估有助于確定是否符合獸藥飼料指令法規，評估國外生產過程記錄，將國外機構添加到進口預警名單中，以及發布警告信。
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.基于這些經驗，FDA 認定遠程評估是有價值的監管工具，因此，在某些情況下，能夠協助 FDA 履行保護公眾健康、監督受監管行業以及確保受監管產品符合 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).關于《聯邦食品、藥品和化妝品法案》（FD&C Act）第 704 (a)(4) 條，經 2022 年《食品藥品綜合改革法案》（FDORA）修訂后的該條款，賦予 FDA 權力要求（并要求相關機構提供）FDA 根據《聯邦食品、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，前提是這些機構參與藥品或器械的制造、制備、傳播、調配或加工，或參與受《聯邦食品、藥品和化妝品法案》第 704 (a)(5)(C) 條檢查的生物研究監測（BIMO）檢查的場所或設施（即受此類檢查的場所、實體或設施）。
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.該機構認為，FDA 在適用情況下對受其監管的產品同時使用強制性和自愿性遠程評估，符合公眾健康利益，并且該機構發布本指南是為了向相關方進一步說明該機構可能選擇使用強制性和自愿性遠程評估的情形。
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.該機構發布(bu)本指南也是為了促(cu)進遠程評估實(shi)施方(fang)式的更大一(yi)致性(xing)，包(bao)括解釋對遠程評估請(qing)求(qiu)的回應流程，以及(ji)概述用于(yu)評估機構是否及(ji)時、適當(dang)地(di)回應強(qiang)制性(xing)遠程評估請(qing)求(qiu)的因素。

Ⅲ. Questions and Answers三、問答
This section is intended to provide FDA’s current thinking regarding the requesting, conducting, and use of RRAs by FDA.本節旨在提供美國食品藥品監督管理局（FDA）目前對于請求、開展和使用遠程監管評估（RRA）的想法。
A.Remote Regulatory Assessment FundamentalsA. 遠程(cheng)監管(guan)評(ping)估基本(ben)原(yuan)理

1.What is an RRA?1.什么是遠程監管評估（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.遠程監管評估是對受 FDA 監管的機構及其記錄進行的完全遠程檢查，以評估其是否符合適用的 FDA 要求。遠程監管評估有助于保護人類和動物健康，為監管決策提供信息，并核實提交給該機構的某些信息。
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.遠程(cheng)(cheng)監(jian)管(guan)(guan)評(ping)(ping)估(gu)(gu)是 FDA 可(ke)用(yong)于支(zhi)持監(jian)管(guan)(guan)決策和監(jian)督活(huo)動的一種工具。強(qiang)制(zhi)性遠程(cheng)(cheng)監(jian)管(guan)(guan)評(ping)(ping)估(gu)(gu)是指根據(ju)法(fa)律(lv)授(shou)(shou)權(quan)要(yao)求(qiu)(qiu)機構(gou)參(can)與(yu)的評(ping)(ping)估(gu)(gu)。根據(ju)《聯(lian)邦食品(pin)、藥品(pin)和化妝(zhuang)品(pin)法(fa)案》（FD&C Act）第(di) 704 (a)(4) 節向機構(gou)索取(qu)記(ji)錄或其(qi)他信息的請求(qiu)(qiu)，以(yi)及根據(ju)《聯(lian)邦法(fa)規(gui)匯編(bian)》（CFR）第(di) 21 篇(pian)第(di) 1.510 (b)(3) 和 1.512 (b)(5)(ii)(C) 節對外國供應商(shang)驗(yan)證(zheng)計劃（FSVP）記(ji)錄的請求(qiu)(qiu)，均屬于強(qiang)制(zhi)性遠程(cheng)(cheng)監(jian)管(guan)(guan)評(ping)(ping)估(gu)(gu)。在(zai)沒有法(fa)定(ding)或監(jian)管(guan)(guan)授(shou)(shou)權(quan)要(yao)求(qiu)(qiu)機構(gou)參(can)與(yu)遠程(cheng)(cheng)監(jian)管(guan)(guan)評(ping)(ping)估(gu)(gu)的情況下進行的遠程(cheng)(cheng)監(jian)管(guan)(guan)評(ping)(ping)估(gu)(gu)是自愿(yuan)性的，在(zai)這種情況下，機構(gou)可(ke)以(yi)選擇(ze)不參(can)與(yu)或退出，此時 FDA 可(ke)能(neng)會考慮使用(yong)其(qi)他工具來評(ping)(ping)估(gu)(gu)其(qi)是否(fou)符合 FDA 的要(yao)求(qiu)(qiu)。

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.

遠程監管評(ping)(ping)估(gu)補充了 FDA 根據(ju)《FD&C Act》第(di) 704 (a)(1) 節(jie)及其他(ta)適用的(de) FDA 授權(quan)進行檢查的(de)權(quan)力。遠程監管評(ping)(ping)估(gu)并不(bu)限制 FDA 根據(ju)《FD&C Act》第(di) 704 (a)(1) 節(jie)及其他(ta)適用的(de) FDA 授權(quan)進行檢查的(de)權(quan)力。

2.Who may be subject to an RRA?

2.哪些對象(xiang)可能(neng)接受遠(yuan)程監管(guan)評估(gu)？

·Mandatory RRAs·強制性(xing)遠程監管評估

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.

強制性遠程監管評估包(bao)括(kuo)以下情(qing)況：(1) 受《FD&C Act》第(di) 704 (a)(4) 節(jie)約束(shu)的(de)(de)(de)機構；(2) 如(ru)《CFR》第(di) 21 篇第(di) 1.500 節(jie)所定義的(de)(de)(de)進口(kou)商，其受《FD&;C Act》第(di) 805 節(jie)下的(de)(de)(de)外國供應商驗證計劃（FSVP）以及《CFR》第(di) 21 篇第(di) 1.510 (b)(3) 或 1.512 (b)(5)(ii)(C) 節(jie)中記錄審查要(yao)求(qiu)的(de)(de)(de)約束(shu)（如(ru)適用(yong)）。

Upon initiating a mandatory RRA, FDA intends to make clear the authorities under which the RRA is being requested.

在啟動(dong)強制性遠程監管評估(gu)時，FDA 打(da)算明確提出該(gai)評估(gu)所依據的授權。

·Voluntary RRAs·自愿性(xing)遠程監(jian)管(guan)評估（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RRA并非由(you)法規或條(tiao)例強制(zhi)(zhi)要求（或者美國食品(pin)(pin)藥(yao)品(pin)(pin)監(jian)督(du)管(guan)(guan)理(li)局（FDA）在特定情況下(xia)選擇不行使其強制(zhi)(zhi)RRA權(quan)力），FDA 可能會要求受其管(guan)(guan)轄的任何企業參與(yu)自愿性(xing)遠程(cheng)監(jian)管(guan)(guan)評(ping)估。

3.Are RRAs replacing other established means of obtaining information outside of inspections?

3. 遠(yuan)程監管評估是否(fou)正在取代檢查(cha)之外的其他既定信息獲取方式(shi)？

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，遠程(cheng)監(jian)管(guan)評估并非旨在(zai)限制或(huo)(huo)取代(dai) FDA 在(zai)檢查之外為實(shi)現其(qi)(qi)公共衛生使(shi)命所需的其(qi)(qi)他(ta)(ta)既(ji)定信(xin)息獲(huo)取方(fang)(fang)式(shi)(shi)，其(qi)(qi)中包括但不限于申(shen)(shen)請(qing)函、監(jian)管(guan)信(xin)息請(qing)求、更新會議、產(chan)品申(shen)(shen)報、申(shen)(shen)請(qing)評估，或(huo)(huo)在(zai)疫情爆(bao)發(fa)或(huo)(huo)其(qi)(qi)他(ta)(ta)緊急(ji)情況下的跟進溝通(tong)。同樣，例(li)如，如果 FDA 聯(lian)系申(shen)(shen)請(qing)人告知其(qi)(qi)某項申(shen)(shen)請(qing)或(huo)(huo)其(qi)(qi)他(ta)(ta)申(shen)(shen)報缺少某些信(xin)息，這些活(huo)動并非遠程(cheng)遠程(cheng)監(jian)管(guan)評估。盡管(guan)這些活(huo)動可(ke)能以遠程(cheng)方(fang)(fang)式(shi)(shi)進行，但 FDA 并不將其(qi)(qi)視為遠程(cheng)監(jian)管(guan)評估。

4. Is an RRA an inspection?

4. 遠程監(jian)管(guan)評估是一種檢查嗎？

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.

遠程(cheng)監管評估并非《聯邦食品、藥(yao)品和(he)化妝品法案》（FD&C Act）第 704 (a)(1) 或 704 (a)(5) 節所定義的檢查。一般而言(yan)，如(ru) FD&C 法案第 704 (a)(1) 節所述的檢查，涉(she)及 FDA 正式(shi)指定的官員(yuan)或雇(gu)員(yuan)（在合理時間以合理方式(shi)）實(shi)際(ji)進(jin)入受 FD&C 法案監管的企業，以確定其(qi)是否符(fu)合適用要(yao)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，由于對外(wai)國供應商驗證計(ji)劃（FSVP）記錄的遠程請(qing)求是(shi)依據 FD&C 法(fa)案(an)第 805 節以及 FDA 的實施(shi)條例授(shou)權進行(xing)的，這些記錄請(qing)求在(zai)功能上等同于檢查，因為 FDA 利用(yong)這些記錄請(qing)求來評估食品進口(kou)商是(shi)否遵守 FSVP 要(yao)求。

5.When may FDA initiate or request to conduct an RRA?

5. FDA 何時可以發起或要(yao)求(qiu)進行遠程監管評估？

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(ding)進行遠程監管(guan)評(ping)估(gu)是適(shi)當的(de)情況下(xia)發起，或者在自愿(yuan)遠程監管(guan)評(ping)估(gu)的(de)情況下(xia)要求進行遠程監管(guan)評(ping)估(gu)，以履行該機構的(de)監管(guan)職(zhi)責并(bing)保護人類和動物健康。例如(ru)：

·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 FDA 因公共衛生緊急情況、自然災害或其他使出行不可行的情況導致的出行限制而無法進行檢查時。
·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.當美國食(shi)品藥品監(jian)督管理(li)局（FDA）確定遠程(cheng)監(jian)管評估（RRA）將有助(zhu)于我們開展對(dui)企業(ye)的(de)監(jian)管工作或(huo)(huo)支持監(jian)管決策時。例如為已計劃好(hao)的(de)檢(jian)查(cha)(cha)做準備、跟進消費者投(tou)訴、協助(zhu)核實企業(ye)已完成某(mou)些糾正措施（例如，針(zhen)對(dui)之前的(de)檢(jian)查(cha)(cha)或(huo)(huo)之前的(de)遠程(cheng)監(jian)管評估），或(huo)(huo)支持對(dui)上(shang)市申報材料的(de)審(shen)查(cha)(cha)。

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.

美國食品藥品監督管理(li)局（FDA）打算采用基于風險的(de)(de)方法來決定是(shi)否發(fa)起(qi)或要(yao)求(qiu)進(jin)行(xing)遠程監管評(ping)估（RRA）。可能考(kao)慮(lv)的(de)(de)因(yin)(yin)素包(bao)括(kuo)但不(bu)限(xian)于企業(ye)所(suo)在地(di)、檢查歷史、產品和(he)生產流程的(de)(de)復雜程度以及出行(xing)限(xian)制。FDA 內部(bu)的(de)(de)項目和(he)中心可能會根據上(shang)述及其他因(yin)(yin)素，以不(bu)同方式(shi)評(ping)估潛在遠程監管評(ping)估中的(de)(de)風險。

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.

以上示例僅作說明之用，最終是否(fou)發起(qi)或要求進(jin)行(xing)遠(yuan)程監管評估(gu)（RRA）的(de)決定(ding)權在(zai) FDA，因為我們保留在(zai)適當情況下使用 RRA 的(de)自由裁量權。FDA 不接受進(jin)行(xing) RRA 的(de)請(qing)求。當 FDA 判定(ding)有必要進(jin)行(xing)檢查（而非 RRA）時，FDA 打算進(jin)行(xing)檢查。

6.Will FDA use RRAs during or as part of an FDA inspection of an establishment?

6.美國食品藥品監督(du)管理局（FDA）在對企業(ye)進(jin)行檢查期間，會將(jiang)遠程(cheng)監管評估（RRA）作為檢查的一(yi)部分來使用嗎(ma)

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，美國食(shi)品(pin)(pin)藥(yao)品(pin)(pin)監(jian)督管(guan)理局（FDA）不計(ji)劃同時(shi)根據《聯邦食(shi)品(pin)(pin)、藥(yao)品(pin)(pin)和(he)(he)化妝(zhuang)品(pin)(pin)法(fa)案》（FD&C Act）第 704 (a)(1) 或 704 (a)(5) 節對企業進行遠程(cheng)監(jian)管(guan)評估（RRA）和(he)(he)檢(jian)(jian)(jian)查(cha)(cha)(cha)。RRA 由 FDA 工作人(ren)員(yuan)遠程(cheng)進行，FDA 工作人(ren)員(yuan)無需親(qin)自到(dao)企業現場開展(zhan)檢(jian)(jian)(jian)查(cha)(cha)(cha)。不過，RRA 可能在(zai)(zai)檢(jian)(jian)(jian)查(cha)(cha)(cha)之(zhi)前(qian)進行、促成檢(jian)(jian)(jian)查(cha)(cha)(cha)或作為檢(jian)(jian)(jian)查(cha)(cha)(cha)的(de)后(hou)續(xu)行動。當 RRA 在(zai)(zai)檢(jian)(jian)(jian)查(cha)(cha)(cha)之(zhi)前(qian)進行時(shi)，FDA 通(tong)常會(hui)(hui)(hui)在(zai)(zai)啟動檢(jian)(jian)(jian)查(cha)(cha)(cha)前(qian)完成該(gai) RRA。FDA 可能會(hui)(hui)(hui)將從 RRA 中獲得的(de)任(ren)何信息(xi)與后(hou)續(xu)檢(jian)(jian)(jian)查(cha)(cha)(cha)中產生的(de)任(ren)何觀(guan)(guan)察(cha)(cha)結(jie)(jie)果(guo)結(jie)(jie)合起來。在(zai)(zai)這種(zhong)情況下，FDA 會(hui)(hui)(hui)在(zai)(zai)后(hou)續(xu)檢(jian)(jian)(jian)查(cha)(cha)(cha)結(jie)(jie)束時(shi)發布的(de)任(ren)何《FDA 483 表格：檢(jian)(jian)(jian)查(cha)(cha)(cha)觀(guan)(guan)察(cha)(cha)結(jie)(jie)果(guo)》中納入(ru) RRA 的(de)觀(guan)(guan)察(cha)(cha)結(jie)(jie)果(guo)之(zhi)前(qian)，在(zai)(zai)后(hou)續(xu)檢(jian)(jian)(jian)查(cha)(cha)(cha)中確認(ren)這些觀(guan)(guan)察(cha)(cha)結(jie)(jie)果(guo)。

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(mei)國食品藥(yao)品監督管(guan)理局（FDA）可能(neng)在檢查(cha)后開展遠程監管(guan)評(ping)估(gu)（RRA），以與企(qi)業(ye)進行后續活動或(huo)在適當情況下(xia)協助核實糾(jiu)正措施(shi)。

FDA may seek to conduct an RRA (e.g., livestreaming) during oversight activities independently conducted by state or foreign regulatory partners.

美(mei)國(guo)食品藥品監督管(guan)(guan)理局（FDA）可能會在州(zhou)或外(wai)國(guo)監管(guan)(guan)合作(zuo)伙伴獨立(li)開展的(de)監管(guan)(guan)活動期(qi)間，尋求進行遠(yuan)程監管(guan)(guan)評估（RRA，例(li)如直播）。

7.What are the benefits of an RRA?

7.遠程監管評估（RRA）的(de)好(hao)處(chu)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:

·美國食品藥品監督管理局（FDA）、行業和公眾均可從遠程監管評估（RRA）中受益，因為 RRA 有助于該機構滿足關鍵的公共衛生需求。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.·允許美國食品藥品監督管理局（FDA）在適當情況下遠程評估受其監管的產品、臨床研究和企業的合規性。這可能發現促使企業及時采取糾正措施的問題，除解決這些問題外，還可能增強企業對下一次 FDA 檢查的準備。
·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，當遠程監管評估（RRA）先于《聯邦食品、藥品和化妝品法案》（FD&C Act）第 704 (a) 節規定的檢查進行時，FDA 可能無需在檢查期間審查過多記錄，從而縮短 FDA 駐留企業的時間。
·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.·在適當條件滿足時（例如(ru)能夠通過(guo)遠程監(jian)管(guan)(guan)評估(gu)（RRA）核實上市申(shen)報(bao)材料中的信(xin)息），幫(bang)助支持無需進(jin)行(xing)檢(jian)查即可及(ji)時做(zuo)出監(jian)管(guan)(guan)決(jue)策(ce)（包括(kuo)批準(zhun)(zhun)申(shen)請(qing)或緊急使用授權）。在此類情況下(xia)，申(shen)請(qing)批準(zhun)(zhun)或授權仍必須(xu)符合適用標(biao)準(zhun)(zhun)。

·Providing FDA additional information to incorporate into a risk-based inspection schedule, thereby helping FDA use inspectional resources more efficiently and effectively.·為美國食品藥品監督管理局（FDA）提供額外信息以納入基于風險的檢查計劃，從而幫助 FDA 更高效且有效地利用檢查資源。協助美國食品藥品監督管理局（FDA）核實糾正措施。
·Assisting FDA in verifying corrective actions.·協助美國(guo)食品藥品監督管理局（FDA）核實糾正(zheng)措施。

B.Remote Regulatory Assessment Expectations

B.遠程(cheng)監(jian)管評(ping)估(gu)要求

8.How may FDA request an RRA?

8.美國食品(pin)藥品(pin)監督管理局(ju)（FDA）如(ru)何請求進行遠程監管評估（RRA）？

FDA generally intends to use the following processes for requesting voluntary or initiating mandatory RRAs.

美國食品藥品監督管(guan)理(li)局（FDA）通常打(da)算采(cai)用(yong)以下流程(cheng)來請求自愿性或發起強制性遠程(cheng)監管(guan)評估（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(qing)求將說(shuo)明遠程監管評估(gu)（RRA）是(shi)強制性(xing)還(huan)是(shi)自愿性(xing)的（如(ru)為(wei)強制性(xing) RRA，還(huan)會(hui)說(shuo)明提出請(qing)求所依據的授權）。

·In general, for voluntary RRAs

·一般而言(yan)，對于自愿性遠程監(jian)管評估（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一般來說(shuo)，對(dui)于自(zi)愿性(xing)遠程監(jian)管評估（RRA），美(mei)國食品(pin)藥品(pin)監(jian)督(du)管理局（FDA）預計在確定(ding)適合開展自(zi)愿性(xing) RRA 后，通(tong)過(guo)企業的聯系人以電(dian)子郵件或電(dian)話方式與(yu)企業取得聯系。

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(mei)國(guo)食品藥品監督管理局（FDA）可(ke)能會利用(yong)企(qi)業(ye)的注冊信(xin)息(xi)、上市申報材料(liao)中提供的企(qi)業(ye)信(xin)息(xi)，或 FDA 可(ke)獲得的其他信(xin)息(xi)，來確(que)定聯系人(ren)、授權官員或美(mei)國(guo)代理人(ren)。

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美國食品藥品監督(du)管(guan)理(li)局(ju)（FDA）將(jiang)在開始自愿性遠程監管(guan)評估（RRA）前獲得企(qi)業對該 RRA 的(de)同(tong)意。在可行的(de)情況下，FDA 通常會(hui)力(li)求以書(shu)面(mian)形(xing)式獲得此類同(tong)意。

oObtaining the establishment’s consent typically includes:

o獲得企業的同意通常(chang)包括(kuo)：

·notifying the establishment’s point of contact of the purpose and planned scope of the RRA and of the right to refuse consent; and

·通知企業聯(lian)系(xi)人遠程監(jian)管評估（RRA）的目的和(he)計劃范圍，以及拒絕(jue)同意的權利(li)；

·requesting that such person confirm that the establishment voluntarily consents and has the ability to participate in the voluntary RRA requested.

·要求該人員確認企業自愿(yuan)同(tong)意并具(ju)備參與(yu)所請(qing)求的(de)自愿(yuan)性遠(yuan)程監管評估（RRA）的(de)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(qing)求的(de)一部分(fen)，FDA 通(tong)常會(hui)為企業(ye)提供討論機(ji)會(hui)，以幫助企業(ye)決定是否同(tong)意自愿性 RRA。此類討論可能會(hui)在(zai)適用且適當的(de)情(qing)況(kuang)下(xia)涵蓋(gai)以下(xia)考量因素，包括(kuo)：

·FDA’s expectations for, and any establishment limitations in participating in, the RRA.

·美(mei)國食(shi)品(pin)藥品(pin)監督管(guan)理局（FDA）對遠程監管(guan)評估（RRA）的(de)預(yu)期，以及企業參與 RRA 的(de)任何限(xian)制。

·The scheduling of virtual interviews and meetings.

·虛擬訪談和會議的時間安排。

·Technological capabilities.

·技術能力。

·The process and timeline for requesting records or other information for review.

·請求(qiu)記錄或其他信息以供審(shen)核的(de)流程和時間安排(pai)。·

·How and when FDA will provide feedback to the establishment.

·美國食(shi)品(pin)(pin)藥品(pin)(pin)監督管(guan)理局（FDA）將如何及何時向企業提供(gong)反饋。

·The general process and other aspects related to logistics and capabilities

·與后(hou)勤和(he)能(neng)力相關的一般流程及其他方面。

·In general, for mandatory RRAs

·一(yi)般而(er)言，對于強(qiang)制性(xing)遠程監(jian)管評(ping)估（RRA）

oFDA will initiate the request in accordance with the relevant legal authority and intends to follow any established procedures.

o美國食品(pin)藥品(pin)監督(du)管理局（FDA）將(jiang)根據相關法律授(shou)權(quan)發起請求，并(bing)打算遵循任何既定程(cheng)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(qi)業注(zhu)冊中列出的聯(lian)系人可作為遠程監管評(ping)估（RRA）請求的聯(lian)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美國食品(pin)藥品(pin)監督(du)管(guan)理局(ju)（FDA）將根據《聯邦食品(pin)、藥品(pin)和化妝(zhuang)品(pin)法案》（FD&C Act）第 704 (a)(4) 條的規定(ding)，使用(yong) FDA 4003 表(biao)格來(lai)請求(qiu)獲(huo)取記(ji)錄或其(qi)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(dui)于(yu)上(shang)市前(qian)批準和(he)上(shang)市前(qian)許(xu)可檢查，可能存在(zai)以(yi)下情況：在(zai)檢查前(qian)，FDA 會根(gen)據(ju)《聯邦食品(pin)(pin)(pin)、藥品(pin)(pin)(pin)和(he)化妝品(pin)(pin)(pin)法案(an)》（FD&C Act）第 704 (a)(4) 條，向(xiang)企(qi)業索要與多個申(shen)請中(zhong)所列產品(pin)(pin)(pin)相關的(de)(de)記錄(lu)。在(zai)此類情況下，FDA 擬向(xiang)該(gai)企(qi)業簽發一份 FDA 4003 表格，以(yi)涵蓋對(dui)所評估申(shen)請中(zhong)相關產品(pin)(pin)(pin)的(de)(de)記錄(lu)或其(qi)他信息的(de)(de)請求。

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當美國食品(pin)藥品(pin)監督(du)管理局（FDA）根(gen)據(ju)《聯邦食品(pin)、藥品(pin)和化妝品(pin)法案(an)》（FD&C Act）第 704 (a)(4) 條提(ti)出請求(qiu)時(shi)，將充分描述所請求(qiu)的記錄或其(qi)他(ta)信息(xi)(xi)，并說明(ming)在檢(jian)查前(qian)請求(qiu)此類記錄或其(qi)他(ta)信息(xi)(xi)（或以此替代檢(jian)查）的理由(you)。

oUpon receipt of the requested records, we will provide confirmation of receipt to the establishment.

o收到所請求的記(ji)錄后，我們(men)將向企業提(ti)供收到確認。

9.What might an establishment expect to happen during an RRA?

企業(ye)在遠程(cheng)監管(guan)評估(gu)（RRA）過(guo)程(cheng)中可(ke)能預(yu)期(qi)會發(fa)生什么？

RRAs may entail, but are not limited to, any combination of the following, depending on the type of RRA involved:

根(gen)據(ju)所涉及(ji)的遠(yuan)程監(jian)管評(ping)估(gu)（RRA）類型，其可能包括但(dan)不限于(yu)以下任何(he)組合(he)：

·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(bing)審核記錄及其他信息（這可(ke)能包括來自(zi)電子系(xi)統的(de)記錄或信息，以及非臨床和臨床研(yan)究(jiu)的(de)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(qi)業(ye)負責人員舉(ju)行(xing)線(xian)上會議(yi)，在適當情況(kuang)下審查(cha)向(xiang)FDA提供(gong)的信息、企(qi)業(ye)的電子系(xi)統、運營情況(kuang)及/或標準操作(zuo)規程。FDA與企(qi)業(ye)在線(xian)上會議(yi)之外的互動可能貫穿(chuan)整(zheng)個遠程監管評估（RRA）過程。

·Use of livestream and/or pre-recorded video, where appropriate, to examine facilities, operations, data, and other information.

·在適當(dang)情況下，使用(yong)直播和/或預錄視頻檢(jian)查設施(shi)、操作(zuo)、數據及其他信息。

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可通過屏幕共享和直播/視頻等方式審核電子系統及原始記錄。在整個遠程監管評估（RRA）過程中，FDA會在可行時向企業更新檢查發現和未決問題。FDA將采取合理適當的措施與企業管理層討論檢查發現，以最大程度減少意外、錯誤和誤解。
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(jin)管根據(ju)(ju)相關(guan)法(fa)律(lv)授權開展的強制性遠程監管評(ping)估（RRA）包含(han)此類授權所詳細(xi)規定(ding)的活動，但(dan)被該(gai)授權要(yao)求(qiu)參與強制性 RRA 的企(qi)(qi)業可(ke)(ke)同意參與超出(chu)規定(ding)要(yao)求(qiu)的活動。例如，FDA 可(ke)(ke)能會要(yao)求(qiu)某(mou)企(qi)(qi)業（其(qi)記錄(lu)請求(qiu)依據(ju)(ju)《聯邦食(shi)品(pin)、藥品(pin)和(he)化妝品(pin)法(fa)案(an)》第 704 (a)(4) 條(tiao)）自愿參與 RRA，通過(guo)視頻(pin)流等互動技術配合審核。

10.Are there any consequences for declining to participate in an RRA?10. 拒絕參與遠程監管評估（RRA）會有什么后果嗎？
·Voluntary RRAs

·自愿性(xing)遠程監管評(ping)估(gu)（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(ping)估(gu)(gu)的(de)自愿性質，FDA 不會僅因(yin)企(qi)業(ye)拒絕(jue)自愿性遠程監(jian)管(guan)評(ping)估(gu)(gu)（RRA）而采取執法行(xing)動。FDA 可能會基于企(qi)業(ye)上次檢查(cha)時間、風險評(ping)估(gu)(gu)及其他(ta)相(xiang)關因(yin)素(su)，考慮采取其他(ta)必要的(de)監(jian)管(guan)措施（如(ru) inspections 檢查(cha)）來履行(xing)對(dui)該企(qi)業(ye)的(de)監(jian)督職責。企(qi)業(ye)可拒絕(jue)參與自愿性 RRA，但不得拒絕(jue) FDA 的(de)檢查(cha)。

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(ruo)企業(ye)(ye)拒絕參(can)與自愿性遠程監管評(ping)(ping)估(gu)（RRA），FDA 可能無法(fa)評(ping)(ping)估(gu)其(qi)活(huo)動，除非啟(qi)用(yong)其(qi)他(ta)監管工具(ju)。事實(shi)上，自愿性 RRA 可能是 FDA 評(ping)(ping)估(gu)企業(ye)(ye)的最便捷(jie)方(fang)式，尤其(qi)是當某(mou)些因素導致無法(fa)及時(shi)開展檢查(cha)時(shi)。例如(ru)，在旅行限制等暫時(shi)影響 FDA 檢查(cha)能力的情(qing)況下，若(ruo)缺(que)乏(fa) RRA，FDA 可能需要(yao)(yao)更長(chang)時(shi)間(jian)來評(ping)(ping)估(gu)企業(ye)(ye)，或審核涉及該(gai)企業(ye)(ye)的上市申(shen)請，因為我(wo)們缺(que)乏(fa)必要(yao)(yao)信息。

·Mandatory RRAs

·強制性遠程監管(guan)評估（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(wei)（包括但不(bu)限(xian)于）視為(wei)拒(ju)絕(jue)參(can)與強制(zhi)性遠程(cheng)監管評估（RRA）：未響應、退出參(can)與，或在依據相關法律授權(quan)提出請求時拒(ju)絕(jue)提供記錄。拒(ju)絕(jue)強制(zhi)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(ye)若(ruo)拒絕根據《聯邦食(shi)品、藥品和(he)化妝品法案(an)》第(di)704(a)(4)條提出(chu)的記錄或(huo)其他(ta)信息請求，可能(neng)違反該法案(an)

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(yang)，若(ruo)進口商(shang)(shang)拒絕FDA根據《美國(guo)聯邦法規》第21編第1.510(b)(3)或1.512(b)(5)(ii)(C)條提出的(de)外國(guo)供(gong)應商(shang)(shang)驗(yan)證計劃（FSVP）記錄書面請求，可(ke)(ke)能(neng)(neng)違反(fan)《聯邦食品(pin)、藥(yao)品(pin)和(he)化妝品(pin)法案》第805條，且(qie)該進口商(shang)(shang)申報進口的(de)食品(pin)可(ke)(ke)能(neng)(neng)依據該法案第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 擬對違反《聯邦食品、藥品和化妝品法案》的相關人員³²及(ji)產品采取適當行動。

11.Are there any technological expectations for an RRA?

11. 遠程監管評估（RRA）對技(ji)術(shu)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(shu)要(yao)求將因遠(yuan)程(cheng)監管評估(gu)（RRA）的類型和范(fan)圍(wei)而異。某(mou)些(xie) RRA 涉(she)及(ji)記錄(lu)請(qing)求，記錄(lu)可根據(ju)適用(yong)(yong)情況以(yi)電子方式或其(qi)(qi)他(ta)手(shou)段提交。其(qi)(qi)他(ta) RRA 可能需要(yao)額外技術(shu)能力。例如(ru)(ru)，若 FDA 預期 RRA 可能包(bao)含直播視(shi)頻使(shi)用(yong)(yong)，將詢(xun)問硬(ying)件或網絡連(lian)接情況，以(yi)評估(gu)信息技術(shu)的可操作(zuo)性(xing)、安全(quan)性(xing)及(ji)隱私控(kong)制措施，從而保(bao)護數(shu)據(ju)機密性(xing)。遠(yuan)程(cheng)連(lian)接質量（如(ru)(ru)連(lian)接穩定性(xing)、圖像清晰度(du)、所用(yong)(yong)攝像頭等）應足以(yi)支持 FDA 審(shen)查、觀察(cha)、檢查和評估(gu)所需記錄(lu)、文件及(ji)其(qi)(qi)他(ta)信息（包(bao)括電子系(xi)統）。在可行范(fan)圍(wei)內，所采用(yong)(yong)的技術(shu)還應允許(xu)適當遠(yuan)程(cheng)查看和評估(gu)企(qi)業操作(zuo)（如(ru)(ru)無菌操作(zuo)、設備清潔與調試(shi)、物料稱量與分配、儀器架設、采樣及(ji)檢測等）。

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(qi)業(ye)無(wu)法支持(chi)視頻直播或其(qi)他(ta)(ta)(ta)實(shi)時線上互(hu)動(dong)(dong)，或FDA判定在遠程(cheng)監(jian)管評估（RRA）過程(cheng)中(zhong)通過視頻直播或其(qi)他(ta)(ta)(ta)線上互(hu)動(dong)(dong)無(wu)法充分(fen)檢(jian)(jian)查企(qi)業(ye)情(qing)況或糾正措(cuo)施，FDA可(ke)能會使用其(qi)他(ta)(ta)(ta)可(ke)用工具，或終(zhong)止RRA并考慮采取其(qi)他(ta)(ta)(ta)必要行動(dong)(dong)以履行對該(gai)企(qi)業(ye)的監(jian)管職責(ze)（如開展檢(jian)(jian)查）。

Recommendations for sending records or other information are further explained in Question 15, below.

- 關于提交記錄或其他(ta)信息的(de)建(jian)議將(jiang)在下文第(di)15問中(zhong)進一步說明。

C.Requests for Records or Other Information as Part of Remote Regulatory Assessments

C. 作為遠程監管評估（RRA）一(yi)部分的記錄(lu)或其他(ta)信息請求(qiu)

12.What records or other information may FDA request as part of an RRA?

12. 作為遠程監管評估(gu)（RRA）的一(yi)部分，FDA可能請求哪些(xie)記錄(lu)或(huo)其他(ta)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(dui)于自愿性遠程(cheng)監(jian)管評估（RRA），FDA可能會(hui)請(qing)求(qiu)(qiu)適當(dang)的記錄(lu)或其他信(xin)息，以確(que)定某企(qi)業或FDA監(jian)管的產品是否符合適用要求(qiu)(qiu)。這些記錄(lu)和其他信(xin)息通常與FDA根據(ju)《聯邦食品、藥品和化妝品法案(an)》第704(a)(1)條開展檢查時可能請(qing)求(qiu)(qiu)的內容類(lei)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(dui)于(yu)強制性遠程監管評估（RRA），我們所(suo)請(qing)求(qiu)的(de)記(ji)錄或其(qi)他信(xin)息及其(qi)請(qing)求(qiu)的(de)情形(xing)，將(jiang)符合相關法律授權。例如，根(gen)據(ju)《聯邦食(shi)品(pin)、藥品(pin)和化妝品(pin)法案》第704(a)(4)條，FDA可(ke)請(qing)求(qiu)《聯邦食(shi)品(pin)、藥品(pin)和化妝品(pin)法案》第704條規定的(de)任(ren)何可(ke)接受(shou)檢查的(de)記(ji)錄或其(qi)他信(xin)息。 - 對(dui)于(yu)依(yi)據(ju)《美(mei)(mei)國聯邦法規》第21編(bian)第1.510(b)(3)和1.512(b)(5)(ii)(C)條開展(zhan)的(de)強制性RRA，FDA可(ke)請(qing)求(qiu)《美(mei)(mei)國聯邦法規》第21編(bian)第1部分(fen)L子部分(fen)要求(qiu)保(bao)存的(de)任(ren)何及所(suo)有記(ji)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(qiang)制性遠程監管評估(gu)（RRA）中可能請求的記錄或其(qi)他信息示例(li)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.

·特定生產批次(ci)記(ji)錄及(ji)產品相關信息，例如定期產品審(shen)核、產品質量報(bao)告、設備(bei)記(ji)錄、工(gong)藝(yi)驗(yan)證記(ji)錄與報(bao)告、檢測結(jie)果(guo)、產品上市(shi)后缺(que)陷記(ji)錄，或其他與符(fu)合現行良好(hao)生產規范（CGMP）要求相關的信息。

·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(hui)總(zong)(zong)記錄或記錄清(qing)單，例如(ru)已生產(chan)批(pi)次及(ji)(ji)其處理(li)情況的匯(hui)總(zong)(zong)，或與(yu)生產(chan)和(he)檢測相關的偏差(cha)及(ji)(ji)調查匯(hui)總(zong)(zong)。

·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(zi)數(shu)(shu)(shu)(shu)據(ju)庫(ku)的只讀(du)訪問(wen)權(quan)限，或(huo)要求企業(ye)引導我們查看其數(shu)(shu)(shu)(shu)據(ju)庫(ku)中的信息，或(huo)提供企業(ye)從(cong)數(shu)(shu)(shu)(shu)據(ju)庫(ku)生成的數(shu)(shu)(shu)(shu)據(ju)查詢結果或(huo)匯總數(shu)(shu)(shu)(shu)據(ju)。

·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(ye)制定的標準操(cao)作程序（SOP）及相(xiang)關記(ji)錄，用于(yu)記(ji)錄質量體系控制情況和(he)/或證(zheng)明符(fu)合FDA要(yao)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(dui)于外(wai)國供應商(shang)(shang)驗證計劃（FSVP）進口(kou)商(shang)(shang)，相關記錄(lu)包括危害分(fen)析、進口(kou)商(shang)(shang)對(dui)適當供應商(shang)(shang)驗證活(huo)動(dong)的判定、供應商(shang)(shang)驗證活(huo)動(dong)的執行情況(kuang)，及/或(huo)糾正措施記錄(lu)。

·For establishments subject to BIMO inspection, records or data related to the reporting or conduct of FDA-regulated research.

·對于需接受生(sheng)物研(yan)究監(jian)(jian)控（BIMO）檢查的企(qi)業，與FDA監(jian)(jian)管(guan)研(yan)究的報告(gao)或實施相關(guan)的記錄或數據。

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，FDA擬采取適當措施(shi)盡量減(jian)少所請求記(ji)錄或(huo)其(qi)他信息(xi)的數(shu)量，并可(ke)能要求企業合理協助以加快FDA對記(ji)錄的收集和(he)審核。更多詳情見第(di)14問(wen)和(he)第(di)15問(wen)。

13.For what purposes may FDA use the records and other information gathered during an RRA?

13.FDA可將遠程(cheng)監管(guan)評(ping)估（RRA）過程(cheng)中收集的記錄(lu)和(he)其他信息用于哪些(xie)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:

根據遠(yuan)程監管評估(gu)（RRA）的(de)范圍，FDA可(ke)將記錄和其他信息用(yong)于(yu)以下目的(de)（包括(kuo)但不(bu)限于(yu)）：

·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(dui)待(dai)審上市申報資料的評估，包括決定(ding)是否批(pi)準申請或是否發(fa)出回復(fu)（如完整回復(fu)函(han)）。

·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(qi)業或產品是否符合《聯邦食品、藥品和化妝品法(fa)案》《公共衛生服務法(fa)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.

·協助評(ping)估針對所報告(gao)問題或缺陷開展后續檢查的必(bi)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.

·支持監管(guan)會議、警(jing)告信、進口措施、召回行動(dong)(dong)或其他咨詢行動(dong)(dong)等舉措，或為行政(zheng)或司法(fa)行動(dong)(dong)提(ti)供支持。

·Determine the priority of establishments for inspection, particularly a surveillance inspection.

·確定企業的檢(jian)查優(you)先級(ji)，尤其是監(jian)督(du)檢(jian)查的優(you)先級(ji)。

14.If the RRA requests records or other information, what is the timeframe for submitting the records and other information to FDA?

14. 若遠程監管(guan)評估（RRA）要求(qiu)提(ti)供記錄或(huo)其(qi)他信息，向FDA提(ti)交這(zhe)些記錄和信息的時(shi)間框架是怎(zen)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(dui)于強制性遠程(cheng)監(jian)管評(ping)估（RRA），FDA會(hui)要(yao)求(qiu)在符合(he)相(xiang)關法律授權(quan)的時間框(kuang)架內提交記(ji)錄和(he)其(qi)他(ta)信息。對(dui)于自愿性RRA，FDA可能(neng)會(hui)建(jian)議(yi)時間框(kuang)架以確保在合(he)理時間內完成RRA，并期(qi)望企(qi)業積極努力提供所請(qing)求(qiu)的記(ji)錄和(he)其(qi)他(ta)信息。如有必要(yao)，若企(qi)業需要(yao)延期(qi)，應盡(jin)快與(yu)FDA聯系人溝(gou)通。與(yu)FDA對(dui)合(he)理請(qing)求(qiu)時間框(kuang)架的預期(qi)相(xiang)關的情形可能(neng)包括：

·The size, available resources, and capabilities of the establishment, including those that might exist for small businesses.

·企業的(de)(de)規模、可用資源及能(neng)力(li)，包括(kuo)小(xiao)企業可能(neng)具(ju)備的(de)(de)資源與能(neng)力(li)。

·The type, complexity, and volume of the records and other information being requested.

·所請(qing)求記錄及其他信息的類型、復雜程度和數量。

·The reason for the request, such as an application action goal date, deadline, or other time- sensitive reasons.

·請求的原因(yin)，例如申請行動目(mu)標(biao)日期、截止(zhi)期限或其他有時效性的原因(yin)。

·Need for translation of records.

·記錄翻(fan)譯(yi)的需求。

15.How should records or other information in response to an RRA request be provided to FDA?

15. 針對遠程監管評估（RRA）請求(qiu)的(de)記錄或其他信息應如何提(ti)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(fei)另有(you)規(gui)(gui)定，所(suo)請(qing)求(qiu)的(de)記(ji)(ji)錄(lu)或其(qi)他信(xin)息(xi)通(tong)常應以電子格式提交。FDA擬(ni)確定并(bing)使用安全方(fang)式發送所(suo)請(qing)求(qiu)的(de)記(ji)(ji)錄(lu)和信(xin)息(xi)。對于電子文(wen)檔，企業應注明外部(bu)訪(fang)問(wen)限制，并(bing)確保FDA可訪(fang)問(wen)加密和受密碼(ma)保護的(de)文(wen)件。FDA將遵(zun)循管理提交至該機構的(de)記(ji)(ji)錄(lu)和信(xin)息(xi)的(de)保密性及(ji)保存的(de)聯邦(bang)(bang)法律法規(gui)(gui)（例如，參(can)見《美國法典(dian)》第(di)(di)(di)(di)5編第(di)(di)(di)(di)552條(tiao)(b)(4)款、第(di)(di)(di)(di)18編第(di)(di)(di)(di)1905條(tiao)，以及(ji)《聯邦(bang)(bang)法規(gui)(gui)匯編》第(di)(di)(di)(di)21編第(di)(di)(di)(di)20部(bu)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認識到部(bu)分企業以(yi)紙質(zhi)(zhi)形(xing)(xing)式保存(cun)文(wen)件。對于以(yi)紙質(zhi)(zhi)形(xing)(xing)式保存(cun)的(de)(de)被請(qing)求文(wen)件，應盡(jin)可能掃描為可檢索的(de)(de)PDF（便攜式文(wen)檔格式）文(wen)件，并通過FDA指(zhi)定的(de)(de)安全方(fang)式發(fa)送。如果(guo)只能以(yi)紙質(zhi)(zhi)形(xing)(xing)式發(fa)送記錄(lu)副本(ben)，FDA將提供接收記錄(lu)的(de)(de)FDA工作人員(yuan)姓名及(ji)聯系方(fang)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(yao)(yao)求(qiu)提交(jiao)至該(gai)機(ji)構的(de)(de)記錄(lu)(lu)及其他信息(xi)為英(ying)文(wen)(wen)或附(fu)英(ying)文(wen)(wen)翻譯件。若(ruo)提供翻譯件，需驗證翻譯內容完整準確，適當時(shi)應包含翻譯人員的(de)(de)姓名、地(di)址(zhi)及資質簡要(yao)(yao)說明。必要(yao)(yao)時(shi)，回(hui)復(fu)中(zhong)還應附(fu)上原始記錄(lu)(lu)和信息(xi)的(de)(de)副本。對于特定遠程(cheng)監管評(ping)估（RRA），若(ruo)無(wu)法立即(ji)提供經核實的(de)(de)翻譯件，FDA可能要(yao)(yao)求(qiu)在(zai)初(chu)步翻譯后盡(jin)快補充經核實的(de)(de)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(lu)或其他信息是根據《聯邦食品、藥品和化妝品法案》第704(a)(4)條的要求(qiu)提(ti)供(gong)，這些記錄(lu)和信息可通(tong)過(guo)電子或紙質形式提(ti)交。FDA收到記錄(lu)后將予以確認。總體而(er)言，FDA擬保持(chi)溝通(tong)渠道(dao)暢通(tong)，以討論(lun)在(zai)遠程監管評估（RRA）過(guo)程中收到的任何記錄(lu)。

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.

- 對于《聯邦法規匯(hui)編(bian)》第(di)21編(bian)第(di)1.510(b)(3)條(tiao)和第(di)1.512(b)(5)(ii)(C)條(tiao)規定(ding)的遠程監管評估（RRA），記錄(lu)必須以電子形式(shi)發送(song)，或(huo)通(tong)過FDA書(shu)面請求中指(zhi)定(ding)的任何其他(ta)能及(ji)時送(song)達記錄(lu)的方式(shi)提交。

D.Completion of a Remote Regulatory Assessment

D. 遠程監管評估的完(wan)成

16.What may occur upon completion of an RRA?

16. 遠程監管(guan)評估（RRA）完成后可能會發生什么？

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).

- 遠程(cheng)監管(guan)(guan)評估（RRA）完成后，FDA可能會與企業管(guan)(guan)理層召開結(jie)(jie)案(an)會議?¹。在結(jie)(jie)案(an)會議上(shang)，FDA可能會提供一份書(shu)面的(de)(de)RRA觀(guan)(guan)察(cha)結(jie)(jie)果(guo)(guo)清(qing)單(dan)（如有），并對這些觀(guan)(guan)察(cha)結(jie)(jie)果(guo)(guo)進行充分詳細的(de)(de)描述和(he)討論，以確保理解(jie)并促進適當回應。在本指(zhi)南中，RRA觀(guan)(guan)察(cha)結(jie)(jie)果(guo)(guo)的(de)(de)定(ding)義(yi)為：在RRA過程(cheng)中觀(guan)(guan)察(cha)到的(de)(de)條件和(he)/或實(shi)踐，經開展RRA的(de)(de)FDA工作人員判斷，表明可能違反FDA執行的(de)(de)法律。FDA不(bu)打算(suan)為RRA簽發FDA 483表格（檢查觀(guan)(guan)察(cha)結(jie)(jie)果(guo)(guo)）。（有關RRA觀(guan)(guan)察(cha)結(jie)(jie)果(guo)(guo)如何在檢查中確認并列入483表格的(de)(de)討論，見問(wen)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).

- 企業應當知曉，RRA觀察結果的書面清單可能在(zai)首次向企業披露時被依據《信息自由法(fa)》提出公開(kai)(kai)請求(qiu)（參(can)見(jian)《聯邦法(fa)規匯編(bian)》第(di)(di)(di)21編(bian)第(di)(di)(di)20.101(a)條(tiao)），且在(zai)對依法(fa)免于公開(kai)(kai)披露的信息進行適當 redaction（刪改）后可能向公眾公開(kai)(kai)（例如，參(can)見(jian)《美(mei)國法(fa)典》第(di)(di)(di)5編(bian)第(di)(di)(di)552條(tiao)(b)款、第(di)(di)(di)18編(bian)第(di)(di)(di)1905條(tiao)、第(di)(di)(di)21編(bian)第(di)(di)(di)331(j)條(tiao)、第(di)(di)(di)360j(c)條(tiao)、第(di)(di)(di)360nn(e)條(tiao)、第(di)(di)(di)387f(c)條(tiao)，以及《聯邦法(fa)規匯編(bian)》第(di)(di)(di)21編(bian)第(di)(di)(di)20部分(fen)）。

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鼓勵企業在(zai)結(jie)案(an)(an)會(hui)議期(qi)間作出回應，和/或(huo)在(zai)十(shi)五（15）個美國工(gong)作日內針對結(jie)案(an)(an)會(hui)議中收到(dao)的(de)觀察結(jie)果(guo)提供書面(mian)回復(fu)。在(zai)該時(shi)間框架(jia)內就RRA期(qi)間發(fa)現的(de)問題提交給FDA的(de)回復(fu)或(huo)糾正(zheng)措施，通(tong)常會(hui)在(zai)FDA采(cai)取進一步(bu)行(xing)動或(huo)作出決(jue)定(ding)前(qian)得到(dao)考慮。企業回復(fu)可(ke)按《聯邦法規匯編(bian)(bian)》第21編(bian)(bian)第20.103條的(de)規定(ding)公開披(pi)露(lu)，并對非(fei)公開信息進行(xing)適(shi)當刪改。

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(de)RRA觀察結果書面清單并非(fei)該機構的(de)最(zui)終行動或決定。然而(er)，RRA期間收(shou)集的(de)信息(xi)可(ke)能用于(yu)支持此類行動或決定。在(zai)RRA之后，FDA可(ke)能會視(shi)情況進行檢(jian)查或考慮其他行動，包括執法行動。

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.

- 作為遠程(cheng)監管評估(gu)（RRA）流(liu)程(cheng)的一(yi)(yi)部分，FDA通常會準備(bei)一(yi)(yi)份(fen)報告，包含(han)敘述性內容及(ji)支(zhi)持性文件(jian)，總結所審(shen)查的信息、發現的條(tiao)件(jian)和(he)實踐，以及(ji)確(que)定的RRA觀察(cha)結果。一(yi)(yi)般(ban)而言，FDA預計在確(que)定RRA結案后，向企業提供RRA報告敘述部分的書面副本（參見《聯邦(bang)法規(gui)匯(hui)編》第(di)21編第(di)20.64(d)(3)條(tiao)）。屆時(shi)，RRA報告及(ji)其支(zhi)持性文件(jian)也可能在回應(ying)《信息自由法》（FOIA）請求時(shi)，經適(shi)當刪改后予以公(gong)開披(pi)露。

本(ben)文(wen)由廣(guang)州佳譽(yu)醫療器械有限(xian)公司(si)(si)/佛山(shan)浩揚醫療器械有限(xian)公司(si)(si)聯合編輯