FDA Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
标准简介
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于U.S。标准截图
![Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)[附网盘链接]](/img/20210914103547ugy26.jpg)
标准文档说明
标准文档类型为Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)[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
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) Guidance for Industry and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You may 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 As discussed in more detail below, the PMA regulation (21 CFR 814.42(e)) identifies the criteria that, if not met, may serve as a basis for refusing to file a PMA. This guidance is intended to be used by FDA staff and the device industry to help elucidate the broad preclinical and clinical issues that need to be addressed in a PMA and the key decisions to be made during the filing process. Focusing the Agency’s review resources on complete applications will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible. Moreover, with the enactment of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the Medical Device User Fee Amendments of 2007 (MDUFA II), the Medical Device User Fee Amendments of 2012 (MDUFA III), and the Medical Device User Fee 1
Amendments of 2017, FDA agreed to performance goals based on the timeliness of reviews. Acceptance review therefore takes on additional importance in both encouraging quality applications from PMA applicants and allowing the Agency to appropriately concentrate resources on complete applications. Therefore, we have modified the PMA filing guidance and checklist. We have separated the criteria for PMA filing into 1) acceptance criteria and 2) filing criteria. Acceptance review involves assessment of the completeness of the application, and informing the applicant in a 1
See Title II of the FDA Reauthorization Act of 2017 (Public Law 115-52)
网盘链接
百度网盘：https://pan.baidu.com/s/1wYkXbUD66G_2_hqDt79jhg
提取码：ysss
【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：63.7038 毫秒
相关评论
相关文章
-
FDA Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)[附网盘链接]是Food&Drug Administration于不久之前发布的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 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 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 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 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。
-
FDA Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels
Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels[附网盘链接]是Food And Drug Administration于不久前发布的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 Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document
Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document[附网盘链接]是FDA于当前发布的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 Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency
Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency[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 Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)
Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)[附网盘链接]是FDA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。