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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 040 Date of Entry 08/14/2015 
FR Recognition Number 13-73
Standard
IHTSDO  SNOMED-CT RF2 Release 2015
Systematized Nomenclature of Medicine - Clinical Terms
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Terms and codes not intended to describe results of in vitro diagnostic tests and terms and codes adopted to describe results of radiologic in vitro diagnostic tests.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
All product codes and regulations under the following parts:
21 CFR 866: Immunology and Microbiology Devices
21 CFR 862: Clinical Chemistry and Clinical Toxicology Devices
21 CFR 864: Hematology and Pathology 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 Contact
 Keith Campbell
  CDRH/OPEQ/OHTVII
  --
  keith.campbell@fda.hhs.gov
Standards Development Organization
IHTSDO International Health Terminology Standards Development Organization (IHTSDO) http://www.snomed.org/
FDA Specialty Task Groups (STG)
Software/Informatics (primary)
InVitro Diagnostics
*These are provided as examples and others may be applicable.
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