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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
ISTA 2 Series Partial Simulation Performance Test Procedure 2A:2011 Packaged-Products 150 lb (68 kg) or less
In determining the basis for this decision, CDRH considered the following documents: ISTA 2 Series Partial Simulation Performance Test Procedure 2A, dated 2011; ISTA Select to expand and show more non-recognition rationale text
JIS H4650:2016 Titanium and titanium alloys -- Bars
The standard include many grades of titanium and titanium alloy for purposes other than medical devices. Recognition limited to Grade 2 titanium is also Select to expand and show more non-recognition rationale text
IEC 61326-2-6 Edition 2.0 2012-07 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
Based upon the scope and the approach to testing, IEC 61326-2-6 describes test planning, including acceptance criteria and a specification of functional performance, immunity Select to expand and show more non-recognition rationale text
IEC 61326-1 Edition 2.0 2012-07 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
Based upon the scope and the approach to testing, IEC 61326-1 describes test planning, including acceptance criteria and a specification of functional performance, immunity 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
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