FDA Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes
标准简介
Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes[附网盘链接]是于之前发布的FDA标准，适用于美国。标准截图
![Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes[附网盘链接]](/img/202109141036182eo05.jpg)
标准文档说明
标准文档类型为Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes[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
Guidance For Industry
Use of Nucleic Acid Tests on Pooled and Individual Samples from
Donors of Whole Blood and Blood Components (including Source
Plasma and Source Leukocytes) to Adequately and Appropriately
Reduce the Risk of Transmission of HIV-1 and HCV
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the appropriate FDA staff. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. INTRODUCTION FDA's blood testing rule requires you, an establishment that collects blood and blood components (e.g. Whole Blood and blood components including Source Plasma and Source Leukocytes), to test each donation of human blood or blood component intended for use in preparing a product, including donations intended as a component of, or used to prepare a medical device, for evidence of infection due to specific communicable disease agents(21 CFR 610.40(a)). This rule also requires you to use one or more approved screening tests as necessary to reduce adequately and appropriately the risk of transmission of communicable disease. (21 CFR 610.40(b)) In the preamble to this final rule, we discussed the approved donor screening tests that we believed were necessary to reduce adequately and appropriately the risk of transmission of Human Immunodeficiency Virus type 1 (HIV-1) and hepatitis C virus (HCV). We also stated that as technology advances, we would issue guidance describing those tests that we believe would adequately and appropriately reduce the risk of transmission of communicable disease agents. (66 FR 31146, 31162 June 11, 2001). The purpose of this guidance is to inform you that: 1) FDA has licensed nucleic acid tests (NAT) as tests to screen blood donors for HIV-1 ribonucleic acid (RNA), and HCV RNA; and 2) these licensed tests can detect evidence of infection at a significantly earlier stage than is possible under previously approved tests using antibody or antigen detection technology; including the HIV-1 p24 antigen test. 1
网盘链接
百度网盘：https://pan.baidu.com/s/1IHrN-MN0POnT1WqZ-HNYLg
提取码：hgjw
【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：33.286 毫秒
相关评论
相关文章
-
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。
-
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 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。