美国FDA CFR21 PART 810 召回程序
美国FDA自动扣留的原则、标准、程序和解决途径
美国FDA自动扣留的原则、标准、程序和解决途径同提交给进口业务部门（DIO）的执法与进口业务办公室（OEIO）。
注意：在任何可行的情况下，建议书应当采用适当的格式以电子方式而非以纸质的方式提交。
在不存在直接引用权时，支持资料应包括分析包及中心许可的文档。
FDA也可根据州或地方机构进行的分析建议不经实际查验即扣留，只要FDA确定由该机构实施的抽样及检验准确可信，并可代表所针对的产品。
若地区部门已向DIOP提交实施不经实际查验即扣留措施的建议但未获批准，根据当地的地方记录，该地区负责人可酌情考虑对今后由特定的包装公司、制造商或承运商通过其港口发运的货物予以扣留。
（欢迎关注CHINA-HACCP）这类货物不需要另外抽样。
涉及农药残留的建议食品安全与应用营养中心（CFSAN）负责对关于含有尚未制定限量标准的农药残留的物品的不经实际查验即扣留措施建议进行审核和批准。
关于该类违规行为的不经实际查验即扣留建议书应当同时提交给食品安全与应用营养中心和进口业务部门。
对已制定限量标准的农药残留所导致的不经实际查验即扣留的建议书，应直接提交给强制执行与进口业务办公室/进口业务部门。
直接引用权限建议书某些对不经实际查验即扣留措施的建议书应被看作取得了相关中心机构的同意。
这类扣留包括涉及陶瓷制品的建议书——陶瓷制品被怀疑含有污染性的铅或镉，其含量超过当前机构准则所规定的水平（CPG第545.400节和第545.450节）；由于含有李斯特菌而对即食海产品及进口奶酪实施不经实际查验即扣留的措施建议书；涉及含沙门氏菌即食海产品的建议书；对外科医生及患者的检验手套实施不经实际查验即扣留的措施建议书；对含沙门氏菌的动物饲料不经实际查验即扣留的措施建议书；以及对乳胶避孕套不经实际查验即扣留的措施建议书。
上述内容未包括所有适用情形。
基于机构检查报告、其他政府机构、谅解备忘录等的建议书当由FDA、国外或者其他政府机构依照谅解备忘录或其他协议实施的检查表明可以对某些特定的产品或由某个公司或在某个特定地区生产的所有产品实施扣留时，相关中心机构根据食品与饲料业务办公室（OFFO）或医疗产品与烟草业务办公室（OMPTO）的建议，在收到机构检查报告（EIR）或其他文件后，应当向进口业务部门提交一份不经实际查验即扣留的措施建议书。
fda 820 法规 -回复
fda 820 法规-回复FDA 820 法规之探讨引言：FDA 820 法规，也被称为FDA 21 CFR Part 820，是针对于医疗器械制造商制定的一套品质体系要求。
本文将从背景、内容、实施步骤等方面对FDA 820 法规进行一步一步的回答和探讨。
通过深入了解这一法规的内涵与实施要求，可以帮助医疗器械制造商更好地满足这些要求并确保产品质量。
第一步：背景介绍FDA 820 法规于1996年颁布并于2003年更新。
它是美国食品药品监督管理局（FDA）为确保医疗器械制造商的产品质量和安全性而制定的一项法规。
FDA 820 法规要求制造商建立和实施一套有效的品质体系，以确保产品质量符合规定的标准。
第二步：法规内容FDA 820 法规包含了一系列的要求，涵盖了医疗器械的设计和开发、制造、包装、标签、存储、售后服务等各个环节。
以下是其中的一些主要要求：1. 体系文件：制造商需要建立一系列文件，包括质量手册、程序文件、工作指导书等，这些文件详细规定了制造商在各个环节的操作方法和要求。
2. 管理责任：制造商需要明确各个管理层级的职责和权力，确保体系的正常运行和持续改进。
3. 设计控制：制造商需要建立有效的设计开发流程，确保产品的设计满足规定的性能要求，并记录和管理任何设计变更。
4. 工艺控制：制造商需要规定和控制生产工艺，确保产品能够稳定地满足规定的质量要求。
5. 供应商控制：制造商需要建立供应商评估和选择的程序，确保所采购的材料和服务能够满足质量要求。
6. 设备和设施控制：制造商需要对生产设备和工作场所进行有效的控制和管理，确保它们符合设定的要求。
7. 检测和测量：制造商需要建立一套适当的检测和测量方法，确保产品能够在各个阶段满足规定的质量标准。
8. 售后服务：制造商需要建立售后服务体系，包括客户投诉的收集和处理，以及产品召回等应急措施。
以上仅是一些主要要求，制造商还需遵守更多的具体要求，以确保医疗器械质量符合FDA的规定。
MGS-MP-21产品召回管理程序
产品召回管理程序生效日期：文件批准日期编制部门：质量部修订记录一、目的为了有效召回已经交到顾客已发生的或将要发生的不安全的产品，保护顾客和消费者的权利，防止不安全危害的发生，特指定本规定二、适用范围适用于本公司生产已经交付给顾客不安全或潜在不安全的产品召回或撤柜。
三、名词定义3.1质量事故定义：能导致危及人体损伤或造成不安全状态的缺陷、产品的极重要质量特性不符合规定，或质量特性特严重不符合规定的，我们定位为质量事故。
3.2产品召回：产品召回是一种公司自主进行或在监管部门要求下进行的召回产品的行为，指从市场或各分销商手中召回大量不合格或冒牌产品（指未通过官方验证的）的有效措施。
3.3产品退回：指产品触犯或因小范围内触犯法律法规，根据现行政策未被官方扣押的产品。
3.4现货寻回：指的是产品还没有离开生产商或初级分销商的范围，如果产品还在分销环节上，这种行动就称为现货寻回或市场召回。
3.5检验效果：根据监管机构的坚定，以保证产品召回或撤回确实实现了，特别是证明该相关活动的实施的与相关客户的来信中。
3.6产品撤柜:公司职能部门发现已经交给客户的产品可能存在小的安全问题，及时通知客户或分销商将产品撤柜。
三、职责4.1 本企业由总经理全权负责产品召回的决策和实施。
任何可能导致召回产品的信息必须立即通知到总经理。
4.2 总经理协调各部门包括生产管理部门及行政部门或其它相关部门组织开展针对该问题的风险评估。
评估小组的评估需要经过公司领导的回顾和批准。
4.3 总经理根据产品风险评估结果决定是否需要召回产品或采取其它必要的行动，例如为了控制不合格产品需要立即停止生产，冻结库存和停止发运等适当行动。
4.4 品保部4.4.1负责收集召回或撤柜产品的相关信息，信息源包括：a) 各个与质量有关的部门通过内部控制，自己发现b) 顾客的信息反馈与投诉c) 本国或产品进口国的法律法规变化d) 本国或产品进口国的官方公布各个部门收集到的有关召回或撤柜产品的信息都要在第一时间传达到品保部4.4.2负责制定不安全或潜在不安全产品的召回或撤柜计划，负责协助召回或撤柜计划的实施并负责产品召回或撤柜后的跟踪监督4.5总经理批准产品召回或撤柜计划的实施4.6召回小组负责实施召回或撤柜计划4.7生产管理部负责对召回或撤柜的产品进行处理五、工作程序：5.1产品召回和撤柜的分类当发现已经交给客户存在的产品存在不安全或潜在不安全因素时，相关的部门实施产品召回，品保部首先按照对客户的危害程度进行分类5.1.1第一类紧急召回：指在紧急情况下，由于产品的缺陷对人的生命健康造成当前或长期的严重威胁，应从所有的销售渠道撤销产品的销售。
美国FD21CFR820法规培训教学课件
21CFR820条款讲解——G生产及过程控制
Sec. 820.75 Process Validation 过程确认 （a）当某个过程的结果不能通过其后的检验和试验完全验 证时 , 该过程应通过高保证进行确认并依据已建立的程序进行批 准 。确认的活动和结果, 包括确认批准人的签名、日期, 适用 时被确认的主要设备应该被文件化
21CFR820条款讲解——G生产及过程控制
Sec. 820.70 Production and Process controls 生产及过程控制 总则 为确保器械符合其规范的要求，制造商应对生产过程进行开发、管理、控 制和监督。作为制造过程的结果，在任何可能发生与器械规范出现偏差的情况 ，制造商都应该建立和保持生产过程控制程序，描述所有必需的过程控制 ，确保符合规格。过程控制应包括: 文件化指引、标准操作规程以及定义并控制生产方式的方法； 在生产过程中，监测和控制过程参数、组件和器械特性； 符合相关的标准或法规； 过程和加工设备的批准； 标准的工艺，应在文件化的标准中加以明确，或通过标识批准的代表性样品的 加以明确。
PART 03
21CFR820条款讲解
F——标识和可追溯性
21CFR820条款讲解——F标识和可追溯性
Sec. 820.60 Identification 标识 制造商应建立并保持程序, 在接收、生产、交付和安装的 所有过程应当识别产品, 从而防止混用。 Sec. 820.65 Traceability 可追溯性 被预期用于外科植入或支持或维持生命的器械, 根据其标 签提供的使用指南正确使用时不能适当工作, 将对使用者 造成重大伤害。生产这些器械的制造商应建立并保持程序, 通过一个控制号码, 对每一个或每一批次最终器械和适用 的组件进行识别。此程序有助于采取纠正措施。这种标识 应在器械历史记录 （DHR）中被文件化。
美国FDA21CFR0部分关于食品生产企业现行良好操作规范
美国FDA21CFR0部分关于食品生产企业现行良好操作规范首先，21CFR110是美国食品药品监管局（FDA）制定并实施的，关于食品生产企业现行良好操作规范（GMP）的法规。
本文将详细介绍21CFR110的主要内容和要求。
21CFR110的目的是确保食品生产企业采取必要的措施，以确保生产的食品安全、洁净和适合食用。
以下是21CFR110中的主要内容和要求：1.建立和实施合理的卫生程序：食品生产企业应采取合理的卫生程序，确保生产设施、设备、器具和工具的适当清洁，以及避免食品受到污染和交叉污染。
2.开展适当的员工培训：食品生产企业应确保员工接受适当的培训，了解食品安全和卫生标准的重要性，并且能够正确执行卫生程序。
员工应受到适当的监督和指导，以确保他们的行为符合卫生要求。
3.管理供应商：食品生产企业应与供应商建立合作关系，并对供应商进行必要的审查。
企业应确保所采购的原材料和食品符合卫生标准，并确保供应链的可追溯性。
4.控制食品接触表面：食品生产企业应确保与食品接触的表面干净、不受污染，并采取适当的措施防止细菌、化学物质和其他有害物质的传播。
5.确保食品贮存和配送的安全性：食品生产企业应使用适当的方法，确保食品在贮存和配送过程中保持安全，以防止细菌和其他污染源的生长和扩散。
6.建立适当的记录保存系统：食品生产企业应建立记录保存系统，将与生产和质量相关的信息进行记录和保存。
这些记录可以是生产和处理程序、检测和监测结果、培训记录等。
7.实施适当的纠正措施和预防措施：食品生产企业应建立和实施纠正措施和预防控制点（HACCP）计划，以降低食品安全问题的风险。
企业应定期评估HACCP计划的有效性，并根据需要进行调整。
除了上述要求，21CFR110还规定了食品生产企业应该配备必要的设备和工具，如温度计、洗涤剂、消毒剂等，并制定了相关的标准和规定，以确保这些设备和工具的适当使用。
总之，美国FDA的21CFR110是针对食品生产企业制定的现行良好操作规范，以确保食品生产过程中的卫生和安全。
医疗器械召回控制程序
医疗器械召回控制程序医疗器械在实施过程中不可避免地会出现一些质量问题，为了保障患者的安全和健康，制定医疗器械召回控制程序非常重要。
该程序旨在及时发现和处理医疗器械存在的问题，并采取相应的召回措施，以保护患者和医疗机构的利益。
本文将介绍医疗器械召回控制程序的重要性、流程和操作规范。
一、医疗器械召回控制程序的重要性医疗器械召回控制程序的建立和执行对于保障患者的安全至关重要。
一方面，召回控制程序可以帮助及时发现和排查医疗器械中存在的质量问题，有效避免可能对患者造成的风险和伤害。
另一方面，这个程序也可以及时提供给临床医师和相关从业人员有关医疗器械问题的准确信息，确保他们能在遇到问题时迅速采取应对措施，保障医疗机构的声誉和利益。
二、医疗器械召回控制程序的流程1. 监测和发现问题医疗机构应建立健全的监测机制，定期进行医疗器械的质量跟踪，与供应商建立紧密的信息沟通渠道。
一旦发现医疗器械存在质量问题的线索，医疗机构应立即启动召回控制程序。
2. 评估召回的必要性和危害程度医疗机构应成立召回评估团队，进行必要的调查和评估，确定是否需要对特定批次或特定型号的医疗器械进行召回，并评估召回的危害程度和紧急程度。
3. 制定召回计划召回评估团队应根据评估结果制定召回计划，明确召回的范围、目标和流程，并协调相关部门和供应商的合作。
4. 实施召回措施医疗机构应按照召回计划，及时向患者、临床医师和相关从业人员发布召回通知，告知召回的原因、影响范围和召回流程。
同时，医疗机构还应与供应商共同协调召回措施的执行，确保召回的顺利进行。
5. 监控和跟踪召回效果医疗机构应建立监控和跟踪机制，及时了解召回措施的实施效果，并通过持续的沟通与报告，确保召回的有效性和及时性。
三、医疗器械召回控制程序的操作规范1. 召回记录的建立与管理医疗机构应建立完善的召回记录管理制度，记录召回安排和执行过程中的相关信息，包括召回通知的发布时间、范围、目标、执行情况等。
针对21CFRPart820法规的讲解
针对21 CFR Part 820法规的讲解一、FDA的定义FDA（U.S. Food and Drug Administration）的简称，即美国食品药品监督管理局。
它是健康与人类服务部下属的一个机构，由各个中心、办公室、地区办公室以及海外办公室组成。
二、联邦法规条例，第21册相关法规说明21 CFR Part 11 电子签名、电子记录（FDA检查时尽量避免给电子档文件）。
21 CFR Part 71.73.74.80 颜色添加剂。
21 CFR Part 58 良好的实验室规范。
21 CFR Part 50 受试者的保护。
21 CFR Part 801 医疗器械标识。
21 CFR Part 807 注册、列示、510（K）510（K）主要是针对产品的许可，包括了产品的生产商、配件生产商、一级销售商，任何一个独立地址的生产厂都必须向FDA注册。
列示：是指针对销售美国的所有产品都要列示。
21 CFR Part 814 上市前许可。
21 CFR Part 803 医疗器械报告。
21 CFR Part 806 纠正与移除。
21 CFR Part 820 质量体系法规。
21 CFR Part 821 医疗器械追踪。
三、第820部分质量体系法规条款框架（共15部分，31章节）（a）适用性（b）法规说明820.1范围（c）权威性（d）外国制造商A部分总则（e）豁免或改变820.3定义820.5质量体系（a）质量方针（1）职责和权限（b）组织（2）资源820.30管理职责（c）管理评审（3）管理者代表B部分质量体系要求820.22质量审核（d）质量策划（e）质量体系程序820.25人员（a）总则（b）培训（a）总则（b）设计和开发策划（c）设计输入（d）设计输出（e）设计评审C部分设计控制----- 820.30设计控制（f）设计验证（g）设计确认（h）设计转换（i）设计更改（j）设计历史文档（a）文件批准和分发D部分文件控制----- 820.40文件控制（b）文件更改（a）采购、承包方和顾问的评价E部分采购控制----- 820.50采购控制（b）采购资料820.60标识F部分标识和可追溯性820.65 可追溯性（a）总则（b）生产和过程更改（c）环境控制（d）人员820.70 生产和过程控制（e）污染控制（f）建筑物1）维护计划（g）设备（2）检查（h）制造物料（3）调整（i）自动化过程G部分生产和过程控制（a）检验、测量和试验装置控制820.72校验、测量和试验装置（1）校准标准（b）校准（2）校准记录820.75过程确认（a）总则（b）进货验收活动820.80 进货、过程中和成品（c）过程中验收活动器械的验收（d）最终验收活动H部分验收活动（e）验收记录820.86 验收状态（a）不合格产品控制I部分不合格产品------ 820.90 不合格产品（b）不合格评审和处置J部分纠正和预防措施----820.100纠正和预防措施（a）标签完整性（b）标记检验820.120 器械标识（c）标识存储K部分标识和包装控制（d）标签作业820.130 器械包装（e）控制号820.140 搬运（a）对存储区规定文件820.150 存储L部分搬运、存储、分销和包装820.160 分销（b）物料收发方法规定文件820.170 安装（a）机密性820.180 通用要求（b）记录保存期限（1）管理评审（c）例外（2）质量审核（a）器械规范（3）供方审核（b）生产过程规范820.181 器械主记录（c）质量保证程序和规范（d）包装和标识规范（e）安装、维护和服务程序及方法（a）制造日期M部分记录（b）制造数量820.184器械的历史记录（c）放行分销的数量（d）验收记录（e）器械上的主要标签和标识记录（f）器械唯一标识UDI和产品代码UPC820.186 质量体系记录1、抱怨接收流程820.198 抱怨文档2、抱怨评估流程3、抱怨审核流程N部分服务----- 820.200 服务O部分统计技术----- 820.250 统计技术。
美国FDA 21CFR820条文
21CFR 820.25 人員 (1) 應使人員了解若未正確執行所分派的任務時可能會始 醫療器材產生瑕疵。此項了解應屬於訓練之一部份。 (2) 應使執行確認及驗收之人員了解他們在工作上可能遇到 的瑕疵及錯誤，此項了解應成為該等人員工作之一部份。
矯正預防措施
Corrective & Pre(1) 責任與權限。製造商應為管理、執行及評估品質相關工作 的人員，建立適當的責任、授權、及相互關係，並應授予 執行這些任務的人員必要的獨立性和權限。 (2) 資源。製造商應提供適當資源(包括分派合格人員)，以執行 管理、評估及執行其他工作(包括內部品質稽核)，以符合本 部分規定之要求。
21CFR 820.180 紀錄管制一般要求 (a) 保密。若製造商認為紀錄屬於機密文件時，應在紀錄上做 記號，以幫助FDA確定該紀錄是否是本章第20部份有關公 共資訊法規所規定的得公開資料。 (b) 紀錄保存期。本部份規定之紀錄保存期應相當於器材之 設計及預期壽命，但不得少於兩年。(自製造商將產品 上市銷售之日起算)。
21CFR 820.3 定義(Definitions) (1) 製程確效(Process validation)： 指根據客觀證據確定特定製程可以產出符合規定規格之 結果或產品。 (2) 設計確認(Design validation)： 指根據客觀證據確定器材規格符合使用者需要及指定用途。 (aa) 查證(Verification)： 指經由審核及提供客觀證據證明已滿足規定要求之過程。
必要時應採取矯正措施，包括對有缺點項目進行複檢。應將各 次品質稽核或複檢結果製作成報告，並由負責受檢項目之管理 階層審核報告。應紀錄品質稽核及複檢日期及結果。
21CFR 820.25 人員 (a) 一般規定。製造商應僱用具備必要教育、背景、訓練及經驗 之人員，以確保正確執行本部分規定之所有要求。 (b) 訓練。製造商應建立確認訓練需求的程序，以確保所有 人員都接受訓練，以正確執行所分派的任務。應將訓練 製作成文件
(完整版)美国FDA《联邦规章典集》(CFR)第21篇目录中文版
美国FDA《联邦规章典集》（CFR）第21篇目录中文版发布时间：2010-5-11 13:44:12 发布方：奥咨达医疗器械咨询美国《联邦规章典集》（CFR）第21篇“食品与药品”总目概述：美国《联邦规章典集》（Code of Federal Regulations，CFR）第21篇“食品与药品”（Title 21―Food and Drugs）共有9卷（Volume）、3章（Chapter）、1499部（Parts）。
其中：第1―8卷第1章第1―1299部，为健康与人类服务部食品与药品管理局（Food and Drug Administration，Department of Health and Human Services）的规章；第9卷第2章第1300―1399部，为司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）的规章；第9卷第3章第1400―1499部，为毒品控制政策办公室（Office of National Drug Control Policy）的规章。
第21篇“食品与药品”（Tit le 21―Food and Drugs）的概况卷（Volume）章（Chapter）部（Parts）规制机关（Regulatory Entity）1 Ⅰ1-99 健康与人类服务部食品与药品管理局（FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）2 100-1693 170-1994 200-2995 300-4996 500-5997 600-7998 800-12999 Ⅱ1300-1399 司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）Ⅲ1400-1499 毒品控制政策办公室（Office of National Drug Control Policy）第21篇“食品与药品”（Title 21―Food and Drugs）的章、部目录部(Part) 中译文原英文第Ⅰ章―健康与人类服务部食品与药品管理局（CHAPTER Ⅰ―FOOD AND DRUG ADMINIST RATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）第A分章―总则（SUBCHAPTER A―GENERAL）1 一般强制执行规章GENERAL ENFORCEMENT REGULATIONS2 一般行政规则与决定GENERAL ADMINISTRATIVE RULINGS AND DECISIONS3 产品管辖权PRODUCT JURISDICTION5 组织ORGANIZATION7 强制执行政策ENFORCEMENT POLICY10 行政规范与程序ADMINISTRATIVE PRACTICES AND PROCEDURES11 电子化记录；电子化签名ELECTRONIC RECORDS; ELECTRONIC SIGNATURES12 正式证据的公众听证FORMAL EVIDENTIARY PUBLIC HEARING13 在公众质询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY14 在公众咨询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE15 在FDA局长前的公众听证PUBLIC HEARING BEFORE THE COMMISSIONER16 在FDA前的规制性听证REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION17 行政罚款听证CIVIL MONEY PENALTIES HEARINGS19 行为标准与利益冲突STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST20 公共信息PUBLIC INFORMATION21 隐私保护PROTECTION OF PRIVACY25 环境影响考虑ENVIRONMENTAL IMPACT CONSIDERATIONS26 药品良好制造规范报告、医疗器械质量体系核查报告以及某些医疗器械产品评价报告的互认：美国与欧共体MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY50 人类受试者的保护PROTECTION OF HUMAN SUBJECTS54 临床试验者的财务公开FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS56 机构审查委员会INSTITUTIONAL REVIEW BOARDS58 对非临床实验室研究的良好实验室规范GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES60 专利期恢复PATENT TERM RESTORATION70 色素添加剂COLOR ADDITIVES71 色素添加剂申请COLOR ADDITIVE PETITIONS73 免除认证的色素添加剂的列表LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION74 适用认证的色素添加剂的列表LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION80 色素添加剂认证COLOR ADDITIVE CERTIFICATION81 用于食品、药品和化妆品的临时性色素添加剂的一般规范和一般限制GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS82 经认证的临时性列表的色素和规范的列表LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS83-98 [预留的] [Reserved]99 已上市的药品、生物制品和器械的未经批准的/新的用途的信息的发布DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES第B分章―用于人类消费的食品（SUBCHAPTER B―FOOD FOR HUMAN CONSUMPTION）100 总则GENERAL101 食品标识FOOD LABELING102 非标准化食品的普通的或者通常的名称COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS104 食品的营养质量指南NUTRITIONAL QUALITY GUIDELINES FOR FOODS105 特殊膳食用途的食品FOODS FOR SPECIAL DIETARY USE106 婴儿配方母乳替代食品质量控制程序INFANT FORMULA QUALITY CONTROL PROCEDURES107 婴儿配方母乳替代食品INFANT FORMULA108 紧急许可控制EMERGENCY PERMIT CONTROL109 在人类食品与食品-包装材料中的不可避免的污染物UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL110 在制造、包装或者保存人类食品中的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD113 装在密封容器中的热加工低酸食品THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS114 酸化食品ACIDIFIED FOODS115 带壳蛋SHELL EGGS119 存在显著或者不合理风险的膳食补充剂DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK120 危害分析与关键控制点（HACCP）体系HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS123 鱼与渔业产品FISH AND FISHERY PRODUCTS129 饮用水加工与装瓶PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER130 食品标准：总则FOOD STANDARDS: GENERAL131 乳与奶油MILK AND CREAM133 乳酪与相关乳酪产品CHEESES AND RELATED CHEESE PRODUCTS135 冷冻点心FROZEN DESSERTS136 烘焙产品BAKERY PRODUCTS137 谷物粉与相关产品CEREAL FLOURS AND RELATED PRODUCTS139 通心粉与面条产品MACARONI AND NOODLE PRODUCTS145 罐装水果CANNED FRUITS146 罐装水果汁CANNED FRUIT JUICES150 水果黄油、果冻、防腐剂以及相关产品FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS152 水果馅饼FRUIT PIES155 罐装蔬菜CANNED VEGETABLES156 蔬菜汁VEGETABLE JUICES158 冷冻蔬菜FROZEN VEGETABLES160 蛋与蛋制品EGGS AND EGG PRODUCTS161 鱼与有壳的水生动物FISH AND SHELLFISH163 可可制品CACAO PRODUCTS164 树坚果与花生制品TREE NUT AND PEANUT PRODUCTS165 饮料BEVERAGES166 人造黄油MARGARINE168 增甜剂与餐桌糖浆SWEETENERS AND TABLE SIRUPS169 食品敷料与调味料FOOD DRESSINGS AND FLAVORINGS170 食品添加剂FOOD ADDITIVES171 食品添加剂申请FOOD ADDITIVE PETITIONS172 允许直接加入用于人类消费食品的食品添加剂FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION173 在用于人类消费的食品中允许的次直接的食品添加剂SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION174 间接食品添加剂：总则INDIRECT FOOD ADDITIVES: GENERAL175 间接食品添加剂：胶粘剂与涂层的组分INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS176 间接食品添加剂：纸与纸板组分INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS177 间接食品添加剂：聚合体INDIRECT FOOD ADDITIVES: POLYMERS178 间接食品添加剂：辅剂、生产助剂和消毒剂INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS 179 在食品生产、加工和处理中的辐照IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD180 在额外试验期间临时在食品或者在与食品接触中被允许的食品添加剂FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY181 先前核准的食品配料PRIOR-SANCTIONED FOOD INGREDIENTS182 一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE184 被确认为一般认为安全的直接食品物质DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE 186 被确认为一般认为安全的间接食品物质INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE 189 禁止用于人类食品的物质SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD190 膳食补充剂DIETARY SUPPLEMENTS191-199 [预留的] [Reserved]第C分章―药品：总则（SUBCHAPTER C―DRUGS: GENERAL）200 总则GENERAL201 标识LABELING202 处方药广告PRESCRIPTION DRUG ADVERTISING203 处方药销售PRESCRIPTION DRUG MARKETING205 对批发处方药销售商颁发州执照的指南GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS206 人用固体口服剂型药品的印码IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE207 药品生产者的登记与商业销售的药品的列表REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION208 处方药的药物治疗指导MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS210 制造、加工、包装或者保存药品的现行良好制造规范；总则CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL211 对完成的药品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS216 药房配药PHARMACY COMPOUNDING225 对含药饲料的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS226 对A型含药物品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES 250 对特殊人用药品的特殊要求SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS290 管制的药品CONTROLLED DRUGS299 药品；正式名称与已确定的名称DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES第D分章―人用药品（SUBCHAPTER D―DRUGS FOR HUMAN USE）300 总则GENERAL310 新药NEW DRUGS312 试验用新药申请INVESTIGATIONAL NEW DRUG APPLICATION314 为FDA批准上市新药的申请APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG315 诊断用放射性药品DIAGNOSTIC RADIOPHARMACEUTICALS316 罕见病药ORPHAN DRUGS320 生物利用度与生物等效性要求BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS328 含有酒精的预期用于口部摄入的非处方药品OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL330 一般认为安全与有效以及不错误标识的非处方人用药品OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED331 用于非处方的人类使用的抗酸产品ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE332 用于非处方的人类使用的抗胃肠气胀产品ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE333 用于非处方的人类使用的局部抗菌药品TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE335 用于非处方的人类使用的止泻药品ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE336 用于非处方的人类使用的止吐药品ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE338 用于非处方的人类使用的帮助夜间睡眠的药品NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE340 用于非处方的人类使用的兴奋药品STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE341 用于非处方的人类使用的感冒、咳嗽、过敏症药、支气管扩张以及平喘药品COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE343 用于非处方的人类使用的内服的止痛、退热以及抗风湿药品INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE344 用于非处方的人类使用的局部的耳部药品TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE346 用于非处方的人类使用的肛肠药品ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE347 用于非处方的人类使用的皮肤保护药品SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE348 用于非处方的人类使用的外部的止痛药品EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE349 用于非处方的人类使用的眼科药品OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE350 用于非处方的人类使用的止汗药品ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE352 用于非处方的人类使用的遮光药品SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]355 用于非处方的人类使用的防龋药品ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE357 用于非处方的人类使用的其他内服药品MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE358 用于非处方的人类使用的其他外用药品MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE361 一般认为安全与有效以及不错误标识的处方人用药品：用于研究的药品PRESCRIPTION DRUGS FOR HUMAN USE GENERALLYRECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH369 在用于非处方销售的药品与器械上关于警告的解释性声明INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE370-499 [预留的] [Reserved]第E分章―动物药品、饮料和相关产品（SUB CHAPTER E―ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS）500 总则GENERAL501 动物食品标识ANIMAL FOOD LABELING502 非标准化的动物食品的普通的或通常的名称COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS509 在动物食品与食品-包装材料中的不可避免的污染物UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL510 新动物药NEW ANIMAL DRUGS511 作为试验用途的新动物药NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE514 新动物药申请NEW ANIMAL DRUG APPLICATIONS515 含药饲料厂执照MEDICATED FEED MILL LICENSE520 口服剂型的新动物药ORAL DOSAGE FORM NEW ANIMAL DRUGS522 植入或者注射剂型的新动物药IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS524 眼科和局部剂型的新动物药OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS526 乳房内的剂型INTRAMAMMARY DOSAGE FORMS529 某些其他剂型的新动物药CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS530 在动物中的特别标签药品使用EXTRALABEL DRUG USE IN ANIMALS556 在食品中新动物药残留的容许量TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD558 用于动物饲料的新动物药NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS564 [预留的] [Reserved]570 食品添加剂FOOD ADDITIVES571 食品添加剂申请FOOD ADDITIVE PETITIONS573 在动物饲料与饮用水中允许的食品添加剂FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS579 在动物饲料和宠物食品的生产、加工和处理中的辐照IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD582 一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE584 在动物饲料与饮用水中被确认为一般认为安全的食品物质FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS589 禁止用于动物食品或者饲料的物质SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED590-599 [预留的] [Reserved]第F分章―生物制品（SUB CHAPTER F―BIOLOGICS）600 生物制品：总则BIOLOGICAL PRODUCTS: GENERAL601 颁发执照LICENSING606 对血液与血液组分的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS607 对人类血液与血液制品的制造者的机构登记与产品列表ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS610 普通生物制品标准GENERAL BIOLOGICAL PRODUCTS STANDARDS630 对血液、血液组分和血液衍生物的一般要求GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES640 对人类血液和血液制品的附加标准ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS660 对用于实验室检测的诊断物质的附加标准ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS680 对其他产品的附加标准ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS第G分章―化妆品（SUBCHAPTER G―COSMETICS）700 总则GENERAL701 化妆品标识COSMETIC LABELING710 化妆品机构的自愿登记VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS720 化妆品配料构成声明的自愿存档VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS740 化妆品警告声明COSMETIC PRODUCT WARNING STATEMENTS741-799 [预留的] [Reserved]第H分章―医疗器械（SUBCHAPTER H―MEDICAL DEVICES）800 总则GENERAL801 标识LABELING803 医疗器械报告MEDICAL DEVICE REPORTING806 医疗器械；改正与移动的报告MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS807 对器械的制造者与首次进口者的机构登记与器械列表ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES808 对州和地方医疗器械要求的联邦优先权的豁免EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS809 人用体外诊断产品IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE810 医疗器械召回权MEDICAL DEVICE RECALL AUTHORITY812 试验用器械豁免INVESTIGATIONAL DEVICE EXEMPTIONS813 [预留的] [Reserved]814 医疗器械的上市前批准PREMARKET APPROVAL OF MEDICAL DEVICES820 质量体系规章QUALITY SYSTEM REGULATION821 医疗器械跟踪要求MEDICAL DEVICE TRACKING REQUIREMENTS822 上市后监视POSTMARKET SURVEILLANCE860 医疗器械分类程序MEDICAL DEVICE CLASSIFICATION PROCEDURES861 性能标准制定程序PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT862 临床化学与临床毒理学器械CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES864 血液学与病理学器械HEMATOLOGY AND PATHOLOGY DEVICES866 免疫学与微生物学器械IMMUNOLOGY AND MICROBIOLOGY DEVICES868 麻醉学器械ANESTHESIOLOGY DEVICES870 心血管器械CARDIOVASCULAR DEVICES872 牙科器械DENTAL DEVICES874 耳、鼻和咽器械EAR, NOSE, AND THROAT DEVICES876 胃肠病学-泌尿学器械GASTROENTEROLOGY-UROLOGY DEVICES878 普通与整形外科器械GENERAL AND PLASTIC SURGERY DEVICES880 普通医院与个人使用器械GENERAL HOSPITAL AND PERSONAL USE DEVICES882 神经学器械NEUROLOGICAL DEVICES884 产科与妇科学器械OBSTETRICAL AND GYNECOLOGICAL DEVICES886 眼科器械OPHTHALMIC DEVICES888 矫形外科器械ORTHOPEDIC DEVICES890 内科学器械PHYSICAL MEDICINE DEVICES892 放射学器械RADIOLOGY DEVICES895 禁止的器械BANNED DEVICES898 电极铅线与患者电缆的性能标准PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES第I分章―乳房造影质量标准法（SUBCHAPTER I―MAMMOGRAPHY QUALITY STANDA RDS ACT）900 乳房造影法MAMMOGRAPHY第J分章―放射学的健康（SUBCHAPTER J―RADIOLOGICAL HEALTH）1000 总则GENERAL1002 记录与报告RECORDS AND REPORTS1003 缺陷与未能守法的通报NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY1004 电子产品的回购、修理或者置换REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS1005 电子产品的进口IMPORTATION OF ELECTRONIC PRODUCTS1010 电子产品的性能标准：总则PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL1020 电离辐射发生产品的性能标准PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS1030 微波与射电频率发生产品的性能标准PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS1040 发光产品的性能标准PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS1050 声波、次声波和超声波发生产品的性能标准PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS第K分章―[预留的]（SUBCHAPTER K―[RESERVED]）第L分章―根据由食品与药品管理局行政执行的某些其他法的规章（SUBCHAPTER L―REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION）1210 根据《联邦进口乳法》的规章REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT1230 根据《联邦腐蚀性毒物法》的规章REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT1240 传染病的控制CONTROL OF COMMUNICABLE DISEASES1250 州际运输卫生INTERSTATE CONVEYANCE SANITATION1251-1269 [预留的] [Reserved]1270 预期用于移植的人体组织HUMAN TISSUE INTENDED FOR TRANSPLANTATION1271 人体细胞、组织以及细胞的和基于组织的产品HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS 1272-1299 [预留的] [Reserved]第Ⅱ章―司法部毒品强制执行局（CHAPTER Ⅱ―DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE）1300 定义DEFINITIONS1301 管制物质的制造者、分销者和调剂者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES1302 对管制物质的标识与包装要求LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES1303 定额QUOTAS1304 登记者的记录与报告RECORDS AND REPORTS OF REGISTRANTS1305 令的格式ORDER FORMS1306 处方PRESCRIPTIONS1307 杂项MISCELLANEOUS1308 管制物质的表SCHEDULES OF CONTROLLED SUBSTANCES1309 表I化学品的制造者、分销者、进口者和出口者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS1310 列入表的化学品和某些机器的记录与报告RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES 1311 [预留的] [Reserved]1312 管制物质的进口与出口IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES1313 前体与必要化学品的进口与出口IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS1314-1315 [预留的] [Reserved]1316 行政职能、规范和程序ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES第Ⅲ章―毒品控制政策办公室（CHAPTER Ⅲ―Office of National Drug Control Policy）1400 [预留的] [Reserved]1401 信息的公众可及性PUBLIC AVAILABILITY OF INFORMATION1402 强制性解密审查MANDATORY DECLASSIFICATION REVIEW1403 对给予州和地方政府资金和合作协议的统一行政要求UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS1404 政府范围的排除与暂停（非获得）GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)1405 对无毒品工作场所的政府范围的要求（财政援助）GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE)1406-1499 [预留的] [Reserved]。
联邦法规第21款 -回复
联邦法规第21款-回复什么是联邦法规第21款？联邦法规第21款是美国联邦政府制定的一项法规，旨在监管食品和药品的安全性、有效性和质量。
该法规由美国食品药品监督管理局（FDA）负责执行，对于涉及食品和药品的生产、销售和使用都具有重要的影响。
它包含了广泛的规定，涵盖了产品注册、标签要求、生产工艺、质量控制、药物剂量和广告宣传等多个方面。
默认情况下，食品和药品在美国的销售和使用是受到联邦法规第21款的约束的。
该法规要求食品和药品的生产商在销售产品之前必须进行注册，并需要在产品上标注相应的信息，包括成分、用途、用法和剂量等。
此外，该法规要求生产商使用合规的生产工艺，并建立质量控制体系，以确保产品的安全性和有效性。
食品和药品的广告宣传也受到联邦法规第21款的限制，禁止虚假宣传和对疾病的不实宣称。
联邦法规第21款的实施过程中有几个重要的步骤和要求。
首先，生产商必须进行产品注册，以便FDA可以进行监管和追溯。
注册要求生产商提供详细的产品信息，包括成分、制造工艺和质量控制措施等。
其次，生产商必须遵守相应的标签要求，必须在产品上标注清楚产品的成分、用途和用法等信息。
如果生产商在标签上进行虚假宣传或未提供必要的警示信息，将会受到法律制裁。
此外，生产商必须建立符合法规要求的质量控制体系，并进行必要的质量管理和检验。
联邦法规第21款还规定了一系列关于食品和药品生产的基本要求。
例如，食品和药品的成分必须符合法规中的规定，并且不能含有禁止使用的物质。
此外，生产商需要采取适当的生产工艺和卫生措施，以确保产品的安全性和卫生标准。
药品的剂量和用法也必须符合法规中的规定，以确保患者获得安全和有效的治疗。
对于违反联邦法规第21款的制造商，FDA有权采取一系列的法律行动，包括警告信、罚款、产品召回和法律起诉等。
此外，FDA还可以对违规企业进行临时禁止销售或制造产品的措施，以保障公众的健康和安全。
在某些严重的违规行为中，FDA还可以直接参与产品的调查和收缴。
医疗器械召回操作程序
医疗器械召回操作程序随着医疗器械的广泛应用，保障患者的安全和权益显得尤为重要。
然而，由于各种原因，可能出现医疗器械存在安全隐患的情况，此时医疗器械召回操作程序就变得至关重要。
本文将详细介绍医疗器械召回操作程序的流程和相关细节，旨在帮助相关部门和人员能够快速、高效地应对医疗器械安全问题。
一、医疗器械召回的定义与分类医疗器械召回是指由于制造缺陷、设计缺陷、信息缺陷等原因，可能给患者带来健康风险的医疗器械需要进行召回的行为。
根据风险的严重程度和受影响的范围，医疗器械的召回可分为三个级别：1. 一级召回：指存在严重安全隐患，可能导致严重伤害甚至死亡的医疗器械，需要立即停止使用并追溯产品流向。
2. 二级召回：指存在安全隐患，可能导致轻微或中度不适的医疗器械，需要停止使用并追溯产品流向。
3. 三级召回：指存在一定安全隐患，但对患者的影响较小的医疗器械，需要进行修复或更换。
二、医疗器械召回操作程序的流程1. 风险评估：当接到医疗器械安全问题的报告后，首先需要进行风险评估，评估该问题的严重程度及其潜在影响范围，确定召回的级别。
2. 召回通知：根据召回级别，制定相应的召回通知，并及时将通知发送给相关医疗机构、经销商和患者。
通知中应包含召回原因、召回的范围、召回的程序和时间要求等信息。
3. 召回计划制定：制定召回计划，明确召回的具体步骤和时间节点。
计划应包括召回的范围、受影响的产品批次、责任部门及人员、召回的方式和联系方式等内容。
4. 召回实施：按照召回计划的要求，开始召回行动。
通常包括以下几个步骤：（1）通知召回对象：通过电话、邮件、短信等方式通知相关医疗机构、经销商和患者，告知召回的原因和程序，并要求将召回产品进行封存。
（2）召回产品收集：设立专门的召回点或回收站，接收召回产品，并对其进行标识、登记和分类。
（3）召回产品处理：对召回产品进行分类处理，如修复、更换、销毁等。
处理过程需要符合相关的法律法规和技术规范。
医疗器械行业-美国销售产品召回程序
医疗器械行业-美国销售产品召回程序1目的建立召回程序以满足FDA相关法规的要求，并在适当的时候实施召回。
2范围适用于需要召回或者FDA强制召回的医疗器械。
3职责3.1 公司各部门职责管理者代表负责组织建立和维护该程序；总裁做出产品召回的判定和批准召回方案；管理者代表负责组织召回的实施，国际市场部、国际用户服务部及其他相关部门配合。
3.2 代理商职责代理商须协助产品调查和产品召回，该要求在进口协议中明确。
4定义本程序采用如下定义，所有定义来源于21CFR810。
4.1 健康严重受损：任何重大的不利事件，可能危及生命或者对人体造成永久伤害，但是不包括那些非威胁生命的或者暂时的和可恢复的伤害。
4.2 召回：是发现某一设备很可能导致健康严重受损时，对设备进行移动、改正或不将其用于人。
4.3 移动：移动设备到另外一个地方，以便修理、修改、调整、重贴标签、销毁或检查设备。
4.4 改正：对设备在原地进行更改、修理、调整、重贴标签或者检查。
5程序5.1 是否召回的判定根据《客户投诉处理流程》的4.2.2节的要求，通过召开重大品质会议对投诉的信息进行分析，判断是否存导致健康严重受损的情况发生或极大可能发生，并由管理者代表报请总裁确定是否需要实施召回。
5.2 如果经总裁批准确定需要实施召回，则由总裁指定专人负责召回。
指定的专人负责如下事宜：5.2.1制定召回方案5.2.2确定召回的实施程度以及收集相关的信息并回复FDA关于召回的问题5.2.3通知FDA以及与召回相关的国外机构5.2.4与FDA沟通召回状态以及召回的分类情况5.2.5负责与联系人、分销商等相关人员的信息交流5.2.6召回按照拟定的方案有效实施5.3 召回的实施5.3.1信息收集本规范5.2节所指定的专人负责收集信息以支持拟定召回实施方案并回答FDA 关于召回的问题：需要召回产品的名称、规格产品信息，如序列号S/N等产品召回原因产品销售情况市场使用数量产品召回方案5.3.2建立联络人档案指定的专人负责确认召回的各联系人，建立联络人档案，并向各联系人以挂号或特快专递邮寄《召回通告信》，表明召回的需求。
医疗器械产品召回的程序与流程
医疗器械产品召回的程序与流程引言：医疗器械的安全性与质量对于患者的生命健康至关重要。
尽管在产品研发和生产过程中严格执行各种质量控制措施，但在某些情况下，仍可能出现医疗器械产品存在缺陷或安全隐患的情况。
为了保障患者利益和维护医疗器械市场的整体安全，医疗器械召回制度被引入并广泛实施。
本文将介绍医疗器械产品召回的程序与流程，以确保执行顺利并有效地解决问题。
一、定义召回医疗器械产品召回是指制造商或经销商主动要求从市场中回收某一批次或系列医疗器械产品的行为。
召回通常是由于产品缺陷、安全隐患或监管机构的建议而引起的。
二、召回的原因1.产品缺陷或安全隐患：医疗器械使用过程中可能出现的产品缺陷或安全隐患是召回的主要原因。
这些缺陷或隐患可能对患者的生命健康带来严重威胁，因此需要及时回收。
2.监管机构的建议：监管机构可能在对医疗器械进行定期检查或监管时发现问题，建议制造商或经销商进行召回。
三、召回的程序与流程1.确定召回的范围和级别：在意识到存在问题之后，制造商或经销商需要确定召回的范围和级别。
范围可以根据产品批次、型号、序列号等不同属性进行划分，级别可以根据问题的严重程度进行划分。
2.制定召回计划：制定召回计划是确保召回执行顺利的关键步骤。
召回计划包括召回通知的内容、召回时间表、召回方式、召回范围等信息。
通常，制造商或经销商需要向监管机构提供召回计划并等待批准。
3.发布召回通知：一旦召回计划获得批准，制造商或经销商需要及时向相关用户（包括医疗机构、医生、患者等）发布召回通知。
召回通知应包括产品召回的原因、影响范围、操作建议等信息。
4.召回执行：制造商或经销商需要开展相应的召回行动，确保产品能够顺利回收。
这通常涉及到与用户的沟通，回收产品的流程安排以及提供替代品或修理方案等。
5.召回跟踪与处理：制造商或经销商需要跟踪召回行动的执行情况，并及时处理回收的产品。
回收的产品通常需要进行检查、修理或销毁处理。
召回结束后，制造商或经销商还需要向监管机构提交召回报告。
美国现行药品生产质量管理规范cGMP(21CFRPart211)
美国现行药品生产质量管理规范（cGMP）目录A-总则 (3)B-组织与人员 (3)C-厂房与设施 (4)D-设备 (7)E-成份、药品容器和密封件的控制 (8)F-生产和加工控制 (11)G-包装和标签控制 (13)H-贮存和销售 (16)I-实验室控制 (17)J-记录和报告 (20)K-退回的药品和回收处理 (25)A．总则211·1 范围(a) 本部分的条例包含人用或兽用药品制备的现行最低限度的药品生产质量管理规范(GMP)。
(b) 在本章里的这些针对药品的现行GMP条例和本章600至800的所有部分针对人用生物制品的现行GMP条例，除非明确另有说明者外，应认为是对本部分条例的补充,而不是代替。
本章其他部分或本章600至680各部分和本部分均可适用的条例,前部分的条例可代替本部分条例。
(c) 在考虑经提议的，发表在1978年9月29日联邦注册表（FR）上一项免除时,若产品及其所有成份是以人用物品形式作一般销售和消费，且这些产品根据其预期用途,亦可列入药品的范围内，则不应对这些非处方药(OTC)实施本部分条例，直至进一步的通知为止。
本章110部分和113至119部分的条例用于鉴别这些亦是食品的OTC药品是否按照GMP的要求生产、加工、包装和贮存。
211·3 定义本章210·3的定义适用于本部分。
B. 组织与人员211.22 质量控制部门的职责(a) 本部门有批准和拒收所有成份、药品包装容器、密封件、中间体、包装材料、标签及药品的职责与权力。
复查生产记录的权力，保证不产生差错，或若发生差错，保证他们充分调查这些差错。
本部门负责根据合同，批准或拒收由其它公司,生产、加工、包装或贮存的产品。
(b) 适当的实验室检验设备、批准（或拒收）的各种成份、药品容器、密封件、包装材料及药品，质量控制部门是可以获得的。
(c) 本部门有批准或驳回影响药品的均一性、效价或含量、质量及纯度的所有程序或规格标准的职责。
美国FDA医疗器械监管模式简介
美国FDA医疗器械监管模式简介美国医疗器械监管模式详细介绍美国医疗器械监管⾄今已有⼀百多年的历史，⽽其监管部门美国⾷品药品管理局（以下简称“FDA”）也已从1862年美国农业部的⼀个化学办公室发展成为世界上重要的⾷品、药品、医疗器械监管机构。
由于美国最早⽴法管理医疗器械，其创⽴的分类管理办法已被普遍接受，因此美国管理医疗器械的法规和模式在国际上有很⼤的影响⼒。
下⾯将从⼏⽅⾯对其管理概况进⾏介绍，以期能够借鉴其先进的监管理念和经验，总结并找出更加适合我国国情的医疗器械监管⽅式。
⼀、⽴法状况1976年美国国会正式通过了《⾷品、药品和化妆品法》（Federal Food，Drug，and Cosmetic Act，简称“FD&C Act”）修正案，加强了对医疗器械进⾏监督和管理的⼒度，并确⽴了对医疗器械实⾏分类管理的办法。
这是国际上第⼀个国家⽴法，并规定由政府⾏政部门对医疗器械进⾏监督管理。
⽽在后续的30多年间，美国国会⼜先后通过了医疗器械安全法案 (SMDA)、乳腺X线设备质量标准法案(MQSA)、FDA监管现代化法案(FDAMA)、医疗器械申报费⽤和现代化法案 (MDUFMA) 、医疗器械申报费⽤稳定法案 (MDUFSA) 、FDA 修正法案(FDAAA)等⼀系列规定，在1976年修正案的基础上⼜增加了许多内容，始终确保法规与医疗器械发展相适应。
美国联邦⾷品药品和化妆品法令是美国联邦法典第九章，通常称其为标题21（Title 21）。
此部分是对⾷品、药物、医疗器械的规定，共9卷，由1-99部分、100-169部分、170-199部分、200-299部分、300-499部分、500-599部分、600-799部分、800-1299部分以及1300部分⾄结束组成，其中前8卷（1-1299部分）包括第I章—⾷品及药物管理局、卫⽣和福利部。
第9卷（1300部分⾄结束）包括第II章—禁药取缔机构、律政司署以及第III章—国家药物控制政策办公室。
FDACFRPart–电子记录和电子签名要求
FDACFRPart–电子记录和电子签名要求FDACFR Part 21–电子记录和电子签名要求引言：随着科技的迅猛发展，电子记录和电子签名在各行业中的应用越来越广泛。
美国食品药品监督管理局（FDA）制定了一系列的规定，旨在确保电子记录和电子签名的合法有效。
本文将详细介绍FDACFRPart 21中关于电子记录和电子签名的要求。
一、背景1.1 电子记录和电子签名的定义根据FDACFR Part 21中的规定，电子记录指通过计算机系统或其他电子手段产生、记录或存储的信息。
而电子签名则是用于验证电子记录的一种电子标识。
1.2 规范的目的和适用范围FDACFR Part 21的目的是确保电子记录和电子签名的真实性、完整性和可靠性，以替代传统的纸质记录和手写签名。
该规范适用于所有FDA监管的行业，包括但不限于食品、药品、医疗器械等。
二、电子记录要求2.1 系统验证和审核使用电子记录的企业应确保其计算机系统符合FDA的规范要求，包括进行恰当的验证和审核。
企业应确保该系统具备记录数据的准确性、完整性和可靠性，并能有效防止非授权访问和篡改。
2.2 记录保留电子记录应保存在可靠的介质上，并按照FDA的规定进行保留。
企业应确保保存的文件完整无缺、难以篡改，并能在需要时快速检索和提取。
2.3 数据完整性和一致性企业应确保电子记录的一致性和完整性。
所有对数据的修改和删除都必须有记录，并有相应的电子签名进行验证和授权。
三、电子签名要求3.1 签名标识电子签名应由唯一且不可复制的标识符生成，并与签名人的身份相关联。
签名标识应具备防护措施，以确保私密性和防止非授权使用。
3.2 签名验证和授权企业应建立验证和授权的过程，以确保电子签名的真实性和有效性。
所有签名都应包含必要的签名属性信息，如签名时间、地点等。
3.3 签名记录和审核企业应实施电子签名记录和审批程序，确保签名记录的保留和审核，并能提供相应的审计跟踪。
四、合规要求的验证和审计4.1 系统验证为了确保计算机系统符合规范要求，企业应实施系统验证计划，并进行周期性的验证测试。
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Title 21: Food and DrugsPART 810—MEDICAL DEVICE RECALL AUTHORITYContentsSubpart A—General Provisions§810.1 Scope. §810.2 Definitions. §810.3 Computation of time. §810.4 Service of orders. Subpart B—Mandatory Medical Device Recall Procedures§810.10 Cease distribution and notification order. §810.11 Regulatory hearing. §810.12 Written request for review of cease distribution and notification order. §810.13 Mandatory recall order. §810.14 Cease distribution and notification or mandatory recall strategy. §810.15 Communications concerning a cease distribution and notification or mandatory recall order. §810.16 Cease distribution and notification or mandatory recall order status reports. §810.17 Termination of a cease distribution and notification or mandatory recall order. §810.18 Public notice.A UTHORITY: 21 U.S.C. 321, 331, 332, 333, 334, 351, 352, 355, 360h, 360i, 371, 374, 375.S OURCE: 61 FR 59018, Nov. 20, 1996, unless otherwise noted.Subpart A—General ProvisionsBack to Top§810.1 Scope.Part 810 describes the procedures that the Food and Drug Administration will follow in exercising its medical device recall authority under section 518(e) of the Federal Food, Drug, and Cosmetic Act.Back to Top§810.2 Definitions.As used in this part:(a) Act means the Federal Food, Drug, and Cosmetic Act.(b) Agency or FDA means the Food and Drug Administration.(c) Cease distribution and notification strategy or mandatory recall strategy means a planned, specific course of action to be taken by the person named in a cease distribution and notification order or in a mandatory recall order, which addresses the extent of the notification or recall, the need for public warnings, and the extent of effectiveness checks to be conducted.(d) Consignee means any person or firm that has received, purchased, or used a device that is subject to a cease distribution and notification order or a mandatory recall order. Consignee does not mean lay individuals or patients, i.e., nonhealth professionals.(e) Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device, without its physical removal from its point of use to some other location.(f) Device user facility means a hospital, ambulatory surgical facility, nursing home, or outpatient treatment or diagnostic facility that is not a physician's office.(g) Health professionals means practitioners, including physicians, nurses, pharmacists, dentists, respiratory therapists, physical therapists, technologists, or any other practitioners or allied health professionals that have a role in using a device for human use.(h) Human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device means an HCT/P as defined in §1271.3(d) of this chapter that does not meet the criteria in §1271.10(a) and that is also regulated as a device.(i) Reasonable probability means that it is more likely than not that an event will occur. 3(j) Serious, adverse health consequence means any significant adverse experience, including those that may be either life-threatening or involve permanent or long-term injuries, but excluding injuries that are nonlife-threatening and that are temporary and reasonably reversible.(k) Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death.(l) Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection. (m) Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of §830.20 of this chapter. A unique device identifier is composed of:(1) A device identifier—a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and(2) A production identifier—a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device:(i) The lot or batch within which a device was manufactured;(ii) The serial number of a specific device;(iii) The expiration date of a specific device;(iv) The date a specific device was manufactured.(v) For an HCT/P regulated as a device, the distinct identification code required by§1271.290(c) of this chapter.[61 FR 59018, Nov. 20, 1996, as amended at 78 FR 55821, Sept. 24, 2013]Back to Top§810.3 Computation of time.In computing any period of time prescribed or allowed by this part, the day of the act or event from which the designated period of time begins to run shall not be included. The computation of time is based only on working days.Back to Top§810.4 Service of orders.4Orders issued under this part will be served in person by a designated employee of FDA, or by certified or registered mail or similar mail delivery service with a return receipt record reflecting receipt, to the named person or designated agent at the named person's or designated agent's last known address in FDA's records.Back to TopSubpart B—Mandatory Medical Device Recall ProceduresBack to Top§810.10 Cease distribution and notification order.(a) If, after providing the appropriate person with an opportunity to consult with the agency, FDA finds that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the agency may issue a cease distribution and notification order requiring the person named in the order to immediately:(1) Cease distribution of the device;(2) Notify health professionals and device user facilities of the order; and(3) Instruct these professionals and device user facilities to cease use of the device.(b) FDA will include the following information in the order:(1) The requirements of the order relating to cessation of distribution and notification of health professionals and device user facilities;(2) Pertinent descriptive information to enable accurate and immediate identification of the device subject to the order, including, where known:(i) The brand name of the device;(ii) The common name, classification name, or usual name of the device;(iii) The model, catalog, or product code numbers of the device;(iv) The manufacturing lot numbers or serial numbers of the device or other identification numbers; and(v) The unique device identifier (UDI) that appears on the device label or on the device package; and5(3) A statement of the grounds for FDA's finding that there is a reasonable probability that the device would cause serious, adverse health consequences or death.(c) FDA may also include in the order a model letter for notifying health professionals and device user facilities of the order and a requirement that notification of health professionals and device user facilities be completed within a specified timeframe. The model letter will include the key elements of information that the agency in its discretion has determined, based on the circumstances surrounding the issuance of each order, are necessary to inform health professionals and device user facilities about the order.(d) FDA may also require that the person named in the cease distribution and notification order submit any or all of the following information to the agency by a time specified in the order:(1) The total number of units of the device produced and the timespan of the production;(2) The total number of units of the device estimated to be in distribution channels;(3) The total number of units of the device estimated to be distributed to health professionals and device user facilities;(4) The total number of units of the device estimated to be in the hands of home users;(5) Distribution information, including the names and addresses of all consignees;(6) A copy of any written communication used by the person named in the order to notify health professionals and device user facilities;(7) A proposed strategy for complying with the cease distribution and notification order;(8) Progress reports to be made at specified intervals, showing the names and addresses of health professionals and device user facilities that have been notified, names of specific individuals contacted within device user facilities, and the dates of such contacts; and(9) The name, address, and telephone number of the person who should be contacted concerning implementation of the order.(e) FDA will provide the person named in a cease distribution and notification order with an opportunity for a regulatory hearing on the actions required by the cease distribution and notification order and on whether the order should be modified, or vacated, or amended to require a mandatory recall of the device.(f) FDA will also provide the person named in the cease distribution and notification order with an opportunity, in lieu of a regulatory hearing, to submit a written request to FDA asking that the order be modified, or vacated, or amended.6(g) FDA will include in the cease distribution and notification order the name, address, and telephone number of an agency employee to whom any request for a regulatory hearing or agency review is to be addressed.[61 FR 59018, Nov. 20, 1996, as amended at 78 FR 55821, Sept. 24, 2013]Back to Top§810.11 Regulatory hearing.(a) Any request for a regulatory hearing shall be submitted in writing to the agency employee identified in the order within the timeframe specified by FDA. Under §16.22(b) of this chapter, this timeframe ordinarily will not be fewer than 3 working days after receipt of the cease distribution and notification order. However, as provided in §16.60(h) of this chapter, the Commissioner of Food and Drugs or presiding officer may waive, suspend, or modify any provision of part 16 under §10.19 of this chapter, including those pertaining to the timing of the hearing. As provided in §16.26(a), the Commissioner or presiding officer may deny a request for a hearing, in whole or in part, if he or she determines that no genuine and substantial issue of fact is raised by the material submitted in the request.(b) If a request for a regulatory hearing is granted, the regulatory hearing shall be limited to:(1) Reviewing the actions required by the cease distribution and notification order, determining if FDA should affirm, modify, or vacate the order, and addressing an appropriate cease distribution and notification strategy; and(2) Determining whether FDA should amend the cease distribution and notification order to require a recall of the device that was the subject of the order. The hearing may also address the actions that might be required by a recall order, including an appropriate recall strategy, if FDA later orders a recall.(c) If a request by the person named in a cease distribution and notification order for a regulatory hearing is granted, the regulatory hearing will be conducted in accordance with the procedures set out in section 201(x) of the act (21 U.S.C. 321(x)) and part 16 of this chapter, except that the order issued under §810.10, rather than a notice under§16.22(a) of this chapter, provides the notice of opportunity for a hearing and is part of the administrative record of the regulatory hearing under §16.80(a) of this chapter. As provided in §16.60(h) of this chapter, the Commissioner of Food and Drugs or presiding officer may waive, suspend, or modify any provision of part 16 under §10.19 of this chapter. As provided in §16.26(b), after the hearing commences, the presiding officer may issue a summary decision on any issue if the presiding officer determines that there is no genuine and substantial issue of fact respecting that issue.(d) If the person named in the cease distribution and notification order does not request a regulatory hearing within the timeframe specified by FDA in the cease distribution and notification order, that person will be deemed to have waived his or her right to request a hearing.7(e) The presiding officer will ordinarily hold any regulatory hearing requested under paragraph (a) of this section no fewer than 2 working days after receipt of the request for a hearing, under §16.24(e) of this chapter, and no later than 10 working days after the date of issuance of the cease distribution and notification order. However, FDA and the person named in the order may agree to a later date or the presiding officer may determine that the hearing should be held in fewer than 2 days. Moreover, as provided for in §16.60(h) of this chapter, the Commissioner of Food and Drugs or presiding officer may waive, suspend, or modify any provision of part 16 under §10.19 of this chapter, including those pertaining to the timing of the hearing. After the presiding officer prepares a written report of the hearing and the agency issues a final decision based on the report, the presiding officer shall provide the requestor written notification of the final decision to affirm, modify, or vacate the order or to amend the order to require a recall of the device within 15 working days of conducting a regulatory hearing.Back to Top§810.12 Written request for review of cease distribution and notification order.(a) In lieu of requesting a regulatory hearing under §810.11, the person named in a cease distribution and notification order may submit a written request to FDA asking that the order be modified or vacated. Such person shall address the written request to the agency employee identified in the order and shall submit the request within the timeframe specified in the order, unless FDA and the person named in the order agree to a later date.(b) A written request for review of a cease distribution and notification order shall identify each ground upon which the requestor relies in asking that the order be modified or vacated, as well as addressing an appropriate cease distribution and notification strategy, and shall address whether the order should be amended to require a recall of the device that was the subject of the order and the actions required by such a recall order, including an appropriate recall strategy.(c) The agency official who issued the cease distribution and notification order shall provide the requestor written notification of the agency's decision to affirm, modify, or vacate the order or amend the order to require a recall of the device within 15 working days of receipt of the written request. The agency official shall include in this written notification:(1) A statement of the grounds for the decision to affirm, modify, vacate, or amend the order; and(2) The requirements of any modified or amended order.Back to Top§810.13 Mandatory recall order.(a) If the person named in a cease distribution and notification order does not request a regulatory hearing or submit a request for agency review of the order, or, if the Commissioner of8Food and Drugs or the presiding officer denies a request for a hearing, or, if after conducting a regulatory hearing under §810.11 or completing agency review of a cease distribution and notification order under §810.12, FDA determines that the order should be amended to require a recall of the device with respect to which the order was issued, FDA shall amend the order to require such a recall. FDA shall amend the order to require such a recall within 15 working days of issuance of a cease distribution and notification order if a regulatory hearing or agency review of the order is not requested, or within 15 working days of denying a request for a hearing, or within 15 working days of completing a regulatory hearing under §810.11, or within 15 working days of receipt of a written request for review of a cease distribution and notification order under §810.12.(b) In a mandatory recall order, FDA may:(1) Specify that the recall is to extend to the wholesale, retail, or user level;(2) Specify a timetable in accordance with which the recall is to begin and be completed;(3) Require the person named in the order to submit to the agency a proposed recall strategy, as described in §810.14, and periodic reports describing the progress of the mandatory recall, as described in §810.16; and(4) Provide the person named in the order with a model recall notification letter that includes the key elements of information that FDA has determined are necessary to inform health professionals and device user facilities.(c) FDA will not include in a mandatory recall order a requirement for:(1) Recall of a device from individuals; or(2) Recall of a device from device user facilities, if FDA determines that the risk of recalling the device from the facilities presents a greater health risk than the health risk of not recalling the device from use, unless the device can be replaced immediately with an equivalent device.(d) FDA will include in a mandatory recall order provisions for notification to individuals subject to the risks associated with use of the device. If a significant number of such individuals cannot be identified, FDA may notify such individuals under section 705(b) of the act.Back to Top§810.14 Cease distribution and notification or mandatory recall strategy.(a) General. The person named in a cease distribution and notification order issued under §810.10 shall comply with the order, which FDA will fashion as appropriate for the individual circumstances of the case. The person named in a cease distribution and notification order9modified under §810.11(e) or §810.12(c) or a mandatory recall order issued under§810.13 shall develop a strategy for complying with the order that is appropriate for the individual circumstances and that takes into account the following factors:(1) The nature of the serious, adverse health consequences related to the device;(2) The ease of identifying the device;(3) The extent to which the risk presented by the device is obvious to a health professional or device user facility; and(4) The extent to which the device is used by health professionals and device user facilities.(b) Submission and review. (1) The person named in the cease distribution and notification order modified under §810.11(e) or §810.12(c) or mandatory recall order shall submit a copy of the proposed strategy to the agency within the timeframe specified in the order.(2) The agency will review the proposed strategy and make any changes to the strategy that it deems necessary within 7 working days of receipt of the proposed strategy. The person named in the order shall act in accordance with a strategy determined by FDA to be appropriate.(c) Elements of the strategy. A proposed strategy shall meet all of the following requirements:(1)(i) The person named in the order shall specify the level in the chain of distribution to which the cease distribution and notification order or mandatory recall order is to extend as follows:(A) Consumer or user level, e.g., health professionals, consignee, or device user facility level, including any intermediate wholesale or retail level; or(B) Retail level, to the level immediately preceding the consumer or user level, and including any intermediate level; or(C) Wholesale level.(ii) The person named in the order shall not recall a device from individuals; and(iii) The person named in the order shall not recall a device from device user facilities if FDA notifies the person not to do so because of a risk determination under §810.13(c)(2).(2) The person named in a recall order shall ensure that the strategy provides for notice to individuals subject to the risks associated with use of the recalled device. The notice may be provided through the individuals' health professionals if FDA determines that such consultation is appropriate and would be the most effective method of notifying patients.(3) Effectiveness checks by the person named in the order are required to verify that all health professionals, device user facilities, consignees, and individuals, as appropriate, have been10notified of the cease distribution and notification order or mandatory recall order and of the need to take appropriate action. The person named in the cease distribution and notification order or the mandatory recall order shall specify in the strategy the method(s) to be used in addition to written communications as required by §810.15, i.e., personal visits, telephone calls, or a combination thereof to contact all health professionals, device user facilities, consignees, and individuals, as appropriate. The agency may conduct additional audit checks where appropriate.Back to Top§810.15 Communications concerning a cease distribution and notification or mandatory recall order.(a) General. The person named in a cease distribution and notification order issued under §810.10 or a mandatory recall order issued under §810.13 is responsible for promptly notifying each health professional, device user facility, consignee, or individual, as appropriate, of the order. In accordance with §810.10(c) or §810.13(b)(4), FDA may provide the person named in the cease distribution and notification or mandatory recall order with a model letter for notifying each health professional, device user facility, consignee, or individual, as appropriate, of the order. However, if FDA does not provide the person named in the cease distribution and notification or mandatory recall order with a model letter, the person named in a cease distribution and notification order issued under §810.10, or a mandatory recall order issued under §810.13, is responsible for providing such notification. The purpose of the communication is to convey:(1) That FDA has found that there is a reasonable probability that use of the device would cause a serious, adverse health consequence or death;(2) That the person named in the order has ceased distribution of the device;(3) That health professionals and device user facilities should cease use of the device immediately;(4) Where appropriate, that the device is subject to a mandatory recall order; and(5) Specific instructions on what should be done with the device.(b) Implementation. The person named in a cease distribution and notification order, or a mandatory recall order, shall notify the appropriate person(s) of the order by verified written communication, e.g., telegram, mailgram, or fax. The written communication and any envelope in which it is sent or enclosed shall be conspicuously marked, preferably in bold red ink: “URGENT—[DEVICE CEASE DISTRIBUTION AND NOTIFICATION ORDER] or [MANDATORY DEVICE RECALL ORDER].” Telephone calls or other personal contacts may be made in addition to, but not as a substitute for, the verified written communication, and shall be documented in an appropriate manner.11(c) Contents. The person named in the order shall ensure that the notice of a cease distribution and notification order or mandatory recall order:(1) Is brief and to the point;(2) Identifies clearly the device, size, lot number(s), code(s), or serial number(s), and any other pertinent descriptive information to facilitate accurate and immediate identification of the device;(3) Explains concisely the serious, adverse health consequences that may occur if use of the device were continued;(4) Provides specific instructions on what should be done with the device;(5) Provides a ready means for the recipient of the communication to confirm receipt of the communication and to notify the person named in the order of the actions taken in response to the communication. Such means may include, but are not limited to, the return of a postage-paid, self-addressed post card or a toll-free call to the person named in the order; and(6) Does not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message.(d) Followup communications. The person named in the cease distribution and notification order or mandatory recall order shall ensure that followup communications are sent to all who fail to respond to the initial communication.(e) Responsibility of the recipient. Health professionals, device user facilities, and consignees who receive a communication concerning a cease distribution and notification order or a mandatory recall order should immediately follow the instructions set forth in the communication. Where appropriate, these recipients should immediately notify their consignees of the order in accordance with paragraphs (b) and (c) of this section.Back to Top§810.16 Cease distribution and notification or mandatory recall order status reports.(a) The person named in a cease distribution and notification order issued under §810.10 or a mandatory recall order issued under §810.13 shall submit periodic status reports to FDA to enable the agency to assess the person's progress in complying with the order. The frequency of such reports and the agency official to whom such reports shall be submitted will be specified in the order.(b) Unless otherwise specified in the order, each status report shall contain the following information:12(1) The number and type of health professionals, device user facilities, consignees, or individuals notified about the order and the date and method of notification;(2) The number and type of health professionals, device user facilities, consignees, or individuals who have responded to the communication and the quantity of the device on hand at these locations at the time they received the communication;(3) The number and type of health professionals, device user facilities, consignees, or individuals who have not responded to the communication;(4) The number of devices returned or corrected by each health professional, device user facility, consignee, or individual contacted, and the quantity of products accounted for;(5) The number and results of effectiveness checks that have been made; and(6) Estimated timeframes for completion of the requirements of the cease distribution and notification order or mandatory recall order.(c) The person named in the cease distribution and notification order or recall order may discontinue the submission of status reports when the agency terminates the order in accordance with §810.17.Back to Top§810.17 Termination of a cease distribution and notification or mandatory recall order.(a) The person named in a cease distribution and notification order issued under §810.10 or a mandatory recall order issued under §810.13 may request termination of the order by submitting a written request to FDA. The person submitting a request shall certify that he or she has complied in full with all of the requirements of the order and shall include a copy of the most current status report submitted to the agency under §810.16. A request for termination of a recall order shall include a description of the disposition of the recalled device.(b) FDA may terminate a cease distribution and notification order issued under §810.10 or a mandatory recall order issued under §810.13 when the agency determines that the person named in the order:(1) Has taken all reasonable efforts to ensure and to verify that all health professionals, device user facilities, consignees, and, where appropriate, individuals have been notified of the cease distribution and notification order, and to verify that they have been instructed to cease use of the device and to take other appropriate action; or(2) Has removed the device from the market or has corrected the device so that use of the device would not cause serious, adverse health consequences or death.13。