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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 063 Date of Entry 12/23/2024 
FR Recognition Number 7-323
Standard
CLSI  EP19 3rd Edition
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
Scope/Abstract
EP19 is organized around the Test Life Phases Model, which is the concept that all test methods undergo establishment by a developer, followed by implementation by the end user, all sequentially. For the purposes of EP19, the term "test method" includes the processes, reagents, supplies, calibrators, control material, hardware, software, and any other components that make up a test. EP19 describes the considerations and processes for planning, performing, and documenting test method evaluations by referring users to the appropriate CLSI EP documents, along with other related documents and resources when applicable. Effective use of EP19 is based on the premise that both the developer and the end user have a QMS in place with appropriate controls over all essential processes, including personnel, environment, general processes, and documentation. Users should refer to CLSI electronic product Method Navigator in conjunction with EP19.
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FDA recognition of CLSI EP19 2nd Edition (Replaces EP19-R) [Rec# 7-266] will be superseded by recognition of CLSI EP19 3rd Edition [Rec# 7-323].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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
21 CFR 58 Good Laboratory Practice for Non Clinical Studies
21 CFR 820 Quality Systems Regulations
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.
FDA Technical Contacts
 Marina V. Kondratovich
  FDA/CDRH/OPEQ/OIDRH/
  301-796-6036
  marina.kondratovich@fda.hhs.gov
 Ying Mao
  FDA/OMPT/CDRH/OPEQ/OHT7/
  --
  Ying.Mao@fda.hhs.gov
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.
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