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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Recognition 08/14/2015 
FR Recognition Number 13-73
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)
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
There is no relevant guidance developed at this time.
FDA Technical Contacts
 Michael Waters
 Steven Gitterman
Standards Development Organization
IHTSDO International Health Terminology Standards Development Organization (IHTSDO) http://www.snomed.org/
FDA Specialty Task Group (STG)