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FDA Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway Draft

蒋千琴 2/8/2022 浏览 222 FDA 美国

标准简介

Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway Draft[附网盘链接]是于不久之前发布的FDA标准，适用于美国。

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Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway Draft[附网盘链接]
Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway Draft[附网盘链接](截图)

 

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标准部分原文

Draft – Not for Implementation

47 Denture Base Resins – Performance 48 Criteria for Safety and Performance 49 Based Pathway

50 ______________________________________________________________________________

51 Draft Guidance for Industry and

52 Food and Drug Administration Staff

53

54 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 55 Administration (FDA or we) on this topic. It does not establish any rights for any person and 56 is not binding on FDA or the public. You can use an alternative approach if it satisfies the 57 requirements of the applicable statutes and regulations. To discuss an alternative approach, 58 contact the FDA staff or Office responsible for this guidance as listed on the title page.

59 I. Introduction

60 This draft guidance provides performance criteria for denture base resins in support of the Safety 1

61 and Performance Based Pathway. Under this framework, submitters (you) planning to submit a 62 510(k) using the Safety and Performance Based Pathway for denture base resins will have the 63 option to use the performance criteria proposed in this draft guidance to support substantial 64 equivalence, rather than a direct comparison of the performance of the subject device to that of a 65 predicate device.

66

67 For the current edition of the FDA-recognized consensus standard(s) referenced in this 2

68 document, see the FDA Recognized Consensus Standards Database. For more information 69 regarding use of consensus standards in regulatory submissions, please refer to the FDA 70 guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 3

71 for Medical Devices. 72

73 The contents of this document do not have the force and effect of law and are not meant to bind 74 the public in any way, unless specifically incorporated into a contract. This document is intended 75 only to provide clarity to the public regarding existing requirements under the law. FDA 76 guidance documents, including this guidance, should be viewed only as recommendations, unless 1

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-

based-pathway 2

Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 3

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-

voluntary-consensus-standards-premarket-submissions-medical-devices

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