FDA Adverse Accreditation Decisions, SuspensionRevocation of Certificates, or Patient and Physician Notification Orders Draft
标准简介
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。标准截图
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标准文档说明
标准文档类型为Adverse Accreditation Decisions, SuspensionRevocation of Certificates, or Patient and Physician Notification Orders Draft[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
Draft – Not for Implementation
59 Appeal Options Available to 60 Mammography Facilities Concerning
61 Adverse Accreditation Decisions, 62 Suspension/Revocation of Certificates, 63 or Patient and Physician Notification 64 Orders
65 ______________________________________________________________________________
66 Draft Guidance for Mammography 67 Facilities and
68 Food and Drug Administration Staff
69
70 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 71 Administration (FDA or Agency) on this topic. It does not establish any rights for any person 72 and is not binding on FDA or the public. You can use an alternative approach if it satisfies 73 the requirements of the applicable statutes and regulations. To discuss an alternative 74 approach, contact the FDA staff or Office responsible for this guidance as listed on the title 75 page.
76
77 I. Introduction 78 This guidance document describes the processes available to mammography facilities to request 79 additional review of an adverse appeals decision on a facility’s accreditation, and/or a suspension 80 or revocation of certificate, and/or a patient and physician notification (PPN) order. This 81 guidance, when final, will supersede section 4.5 of the Center for Devices and Radiological
1
82 Health (CDRH) Appeals Processes guidance document dated July 2, 2019. The remainder of 83 the July 2, 2019 CDRH Appeals guidance, with exception of technical edits for consistency with 84 the newly amended section 4.5, will not be substantively changed and will remain in effect.
85
1
Available on FDA’s website at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/center-devices-and-radiological-health-cdrh-appeals-processes.
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