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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 050 Date of Entry 09/17/2018 
FR Recognition Number 7-283
Standard
CLSI  POCT04 3rd Edition
Essential Tools for Implementation and Management of a Point-of-Care Testing Program
Scope/Abstract
Many potential sites are eligible for point-of-care testing (POCT). To achieve producing patient test results comparable with those from the medical laboratory, this guideline provides essential tools for implementing and managing POCT in both clinical and nonclinical settings.
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.
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
 Kristian Roth
  FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC2/
  301-796-7024
  kristian.roth@fda.hhs.gov
 Stefanie Akselrod
  FDA/OC/CDRH/OPEQ/OIDRH/DMD/VIR1/
  301-796-6188
  stefanie.akselrod@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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