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FDA Electromagnetic Compatibility (EMC) of Medical Devices Draft

蒋千琴 3/22/2022 浏览 230 FDA United States

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Electromagnetic Compatibility (EMC) of Medical Devices Draft[附网盘链接]由Food And Drug Administration于不久前发布，适用于United States。

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Electromagnetic Compatibility (EMC) of Medical Devices Draft[附网盘链接]
Electromagnetic Compatibility (EMC) of Medical Devices Draft[附网盘链接](截图)

 

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标准部分原文

Draft – Not for Implementation

82 Electromagnetic Compatibility (EMC) 83 of Medical Devices

84 ______________________________________________________________________________ 85 Draft Guidance for Industry and 86 Food and Drug Administration Staff 87

88 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 89 Administration (FDA or Agency) on this topic. It does not establish any rights for any person 90 and is not binding on FDA or the public. You can use an alternative approach if it satisfies the 91 requirements of the applicable statutes and regulations. To discuss an alternative approach, 92 contact the FDA staff or Office responsible for this guidance as listed on the title page.

93

94 I. Introduction

95 The Food and Drug Administration (FDA) has developed this guidance document to recommend

96 information that should be provided in a premarket submission (i.e., premarket approval (PMA) 97 application, humanitarian device exemption (HDE), biologics license application (BLA), 98 premarket notification (510(k)) submission, investigational device exemption (IDE) and De 99 Novo request) to demonstrate electromagnetic compatibility (EMC) for electrically powered 100 medical devices and medical devices with electrical or electronic functions. Typically, the review 101 of EMC information in a submission is based on the risk associated with malfunction or 102 degradation of the medical device under consideration, where malfunction or degradation could 103 be caused by inadequate EMC. The review is also based on the use of appropriate consensus 104 standards. This draft guidance, when final, will replace the FDA guidance, “Information to 105 Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical 106 Devices” (hereafter referred to as the 2016 EMC guidance), published July 11, 2016. This draft 107 guidance is not intended to change current policy, but provides additional technical information 108 to address the recommendations in the 2016 EMC guidance. 109

110 For the current edition of the FDA-recognized consensus standard(s) referenced in this 1

111 document, see the FDA Recognized Consensus Standards Database. For more information 112 regarding use of consensus standards in regulatory submissions, please refer to the FDA 113 guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 2

114 for Medical Devices.”

115

1

Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 2

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-

standards-premarket-submissions-medical-devices

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