FDA Center for Devices and Radiological Health (CDRH) Appeals Processes
标准简介
Center for Devices and Radiological Health (CDRH) Appeals Processes[附网盘链接]是Food And Drug Administration发布的FDA标准，适用于美国。标准截图
![Center for Devices and Radiological Health (CDRH) Appeals Processes[附网盘链接]](/img/20210914103606wsxdo.jpg)
标准文档说明
标准文档类型为Center for Devices and Radiological Health (CDRH) Appeals Processes[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Center for Devices and Radiological Health (CDRH) Appeals Processes Guidance for Industry and Food and Drug Administration Staff This guidance represents the Food and Drug Administration's (FDA's) current thinking 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. I. Introduction
This guidance document describes the processes available to outside stakeholders to request additional review of decisions or actions by Center for Devices and Radiological Health (CDRH or the Center) employees. Individuals outside of the Food and Drug Administration (FDA), who disagree with a decision or action taken by CDRH and wish to have it reviewed or reconsidered have several processes for resolution from which to choose, including: Requests for supervisory review of 1
an action; petitions; and hearings. These processes are broadly described in statutes and regulations which pertain to FDA. This document provides general information about each process, as well as guidance on how to submit related requests to CDRH and FDA. Keep in mind as you read over this material that for any situation, multiple processes for resolution may be available. It is up to the party seeking review of an adverse decision or resolution of a difference of opinion to determine the appropriate process for a given circumstance or issue. The most effective means of resolving a dispute between the Center and an external stakeholder is through discussion and agreement prior to the regulatory decision. The CDRH Ombudsman is available to assist in clarifying issues, mediating meetings and teleconferences, and conducting discussions with the parties in an effort to resolve disagreements before a formal request for review. Before contacting the Ombudsman, a stakeholder should have made reasonable efforts to discuss the decision or action in dispute with the individual charged with managing the matter at issue. If such attempt at resolution is 1
Requests for Supervisory Review of an action under section 517A of the FD&C Act; 21 CFR 10.75 and 800.75; Citizen Petitions under 21 CFR 10:30; and Requests for a hearing under 21 CFRs parts 12-16.
网盘链接
百度网盘：https://pan.baidu.com/s/1miAlhMirantbsHJjccFucg
提取码：5h2m
【温馨提示】大资料ISO是提供信息发布的专业信息类网站，所有内容均由用户发布，不代表本站观点，本站亦不存储所涉及的文件及资料。如有【免费资料】以及【付费资料】,请用户根据自己的需求，自行判断是否需要获取。如有交易诈骗、内容侵权可发送邮件至kf@dzl100.com，我们审查后若发现情况属实，会立即对相关内容进行删除处理。
加载用时：61.0999 毫秒
相关评论
相关文章
-
ISO 19206-3:2021 Road vehicles — Test devices for target vehicles, vulnerable road users and other objects, for assessment of active safety functions —Part 3: Requirements for passenger vehicle 3D targets
Road vehicles — Test devices for target vehicles, vulnerable road users and other objects, for assessment of active safety functions —Part 3: Requirements for passenger vehicle 3D targets是ISO于2021‑05‑21发布的ISO标准，适用于全球范围。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
GHTF/SG3/N18:2010 GHTF SG3 - Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes - November 2010 - PDF (254kb)
GHTF SG3 - Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes - November 2010 - PDF (254kb)[附网盘链接]是Study Group 3于4 November 2010发布的GHTF标准，适用于世界。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
GHTF/SG3/N17:2008 GHTF SG3 - Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers - December 2008 - PDF (593kb)
GHTF SG3 - Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers - December 2008 - PDF (593kb)[附网盘链接]是GHTF Study Group 3于December 11, 2008发布的GHTF标准，适用于全球范围。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
IMDRF/GRRP WG/N47 FINAL:2018 Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices - PDF (260kb)
Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices - PDF (260kb)[附网盘链接]是IMDRF Good Regulatory Review Practices Group于31 October 2018发布的GHTF标准，适用于世界。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
ISO 15364:2021 Ships and marine technology — Pressure-vacuum valves for cargo tanks and devices to prevent the passage of flame into cargo tanks
Ships and marine technology — Pressure-vacuum valves for cargo tanks and devices to prevent the passage of flame into cargo tanks是ISO于2021-02-12发布的ISO标准，适用于国际范围。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers
Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers[附网盘链接]是Food&Drug Administration于不久前发布的FDA标准，适用于U.S。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Exculpatory Language in Informed Consent
Exculpatory Language in Informed Consent[附网盘链接]是FDA于不久前发布的FDA标准，适用于美国。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于US。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Adverse Accreditation Decisions, SuspensionRevocation of Certificates, or Patient and Physician Notification Orders Draft
Adverse Accreditation Decisions, SuspensionRevocation of Certificates, or Patient and Physician Notification Orders Draft[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于United States。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
![CVM GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical Products.pdf[网盘链接]](/img/small/20210914103659dm8zg.jpg)
CVM GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical Products.pdf[网盘链接]
GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical Products.pdf是于发布的标准，适用于。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances
Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances[附网盘链接]是FDA于过去发布的FDA标准，适用于美国。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry
Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry[附网盘链接]是FDA于过去发布的FDA标准，适用于美国。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Assay Migration Studies for In Vitro Diagnostic Devices Guidance for Industry and FDA Staff
Assay Migration Studies for In Vitro Diagnostic Devices Guidance for Industry and FDA Staff[附网盘链接]是FDA于过去发布的FDA标准，适用于United States。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format
Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format[附网盘链接]是Food And Drug Administration于当前发布的FDA标准，适用于United States。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
-
FDA Chronic Hepatitis D Virus Infection Developing Drugs for Treatment Guidance for Industry
Chronic Hepatitis D Virus Infection Developing Drugs for Treatment Guidance for Industry[附网盘链接]是Food&Drug Administration于当前发布的FDA标准，适用于United States。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。