Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 045 Date of Entry 09/21/2016 
FR Recognition Number 7-266
Standard
CLSI  EP19 2nd Edition (Replaces EP19-R)
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
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.
Extent of Recognition
Complete standard
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
 Zivana Tezak
  FDA/OC/CDRH/OPEQ/OIDRH/
  301-796-6206
  Zivana.Tezak@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.
-
-