| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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045
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Date of Entry 09/21/2016
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|
FR Recognition Number
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7-266
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| Standard | |
CLSI EP19 2nd Edition (Replaces EP19-R)
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures |
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Scope/Abstract| CLSI EP19-Ed2 uses the "measurement procedure lifecycle" framework to aid users of CLSI evaluation protocols documents during establishment and implementation of measurement procedures developed by both commercial manufacturers and clinical laboratories, ie, for laboratory-developed tests. |
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| Extent of Recognition
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Transition Period
| FDA recognition of CLSI EP19 2nd Edition (Replaces EP19-R) [Rec# 7-266] will be superseded by recognition of CLSI EP19 3rd Edition [Rec# 7-323]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-266] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 7-266] will not be accepted. |
|
Relevant FDA Guidance and/or Supportive Publications*
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
