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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 060 Date of Entry 05/29/2023 
FR Recognition Number 7-315
CLSI  EP12 3rd Edition
Evaluation of Qualitative, Binary Output Examination Performance
EP12 provides product design guidance and protocols for performance evaluation of the Establishment and Implementation Stages of the Test Life Phases Model of examinations (see CLSI document EP191). EP12 characterizes a target condition (TC) with only two possible outputs (eg, positive or negative, present or absent, reactive or nonreactive). EP12 is written for both manufacturers of qualitative, binary, results-reporting or output examinations (referred to as qualitative, binary examinations throughout) and medical laboratories that create laboratory-developed, binary examinations (both termed developers). These protocols are also intended to help users verify examination performance in their own testing environment. Performance evaluation of examinations that provide outputs with more than two possible categories in an unordered (nominal) set or that report ordinal categories are outside the scope of this guideline.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of CLSI EP12-A2 [Rec# 7-152] will be superseded by recognition of CLSI EP12 3rd Edition [Rec# 7-315]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-152] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 7-152] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests, Issued March 2007.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Qin Li
 Marina V. Kondratovich
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.