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U.S. Department of Health and Human Services

Non-Recognized Standards: Medical Devices

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A non-recognized standard is a standard that the FDA has determined does not satisfy or would not be helpful in satisfying a portion of the law. A manufacturer may not declare conformity to a non-recognized standard. Manufacturers choosing to use a non-recognized standard in a premarket submission are referred to Section IV. B. General Use of Consensus Standards in Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices. For additional guidance, please see Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff.

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Standards
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Organization
Standard Designation
Number and Date
Title of Standard
Summary of Rationale for Non-Recognition
UL 60601-1 First Edition 2003 Medical Electrical Equipment, Part 1: General Requirements for Safety
The standard is in conflict with AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated text) Medical electrical equipment - Part 1: General requirements for Select to expand and show more non-recognition rationale text
ISO 20916 First edition 2019-05 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
This ISO standard creates two general buckets of clinical performance studies with different expectations for ethical conduct/IRB review: interventional (e.g., data used for patient Select to expand and show more non-recognition rationale text
ISO 15197 Second edition 2013-05-15 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
"The criteria set forth in the ISO 15197 standard are not sufficient to adequately protect lay-users using SMBGs because, for example, the standard does Select to expand and show more non-recognition rationale text
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