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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 7-275
Standard
CLSI  EP07 3rd Edition
Interference Testing in Clinical Chemistry.
Scope/Abstract
This guideline is intended for manufacturers and medical laboratories. EP07 assists manufacturers and other developers of laboratory measurement procedures in characterizing the effects of potential interferents on measurement procedures results. EP07 also contains background information on interference testing concepts
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
HEMATOLOGY AND PATHOLOGY DEVICES
IMMUNOLOGY AND MICROBIOLOGY DEVICES
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
 Douglas Rheinheimer
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/TB/
  301-796-6157
  douglas.rheinheimer@fda.hhs.gov
 Francisca Reyes Turcu
  FDA/OC/CDRH/OPEQ/OIDRH/DMGP/MPCB/
  301-348-1971
  Francisca.ReyesTurcu@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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