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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 038 Date of Recognition 01/27/2015 
FR Recognition Number 13-71
Standard
RII Version 2.48
Logical Observation Identifiers Names and Codes (LOINC)
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Classes that are radiologic in vitro diagnostic tests or non-in vitro diagnostic tests including the following (listed in alphabetic order):

ART, ATTACH, ATTACH.AMB, ATTACH.CARD, ATTACH.CLINRPT, ATTACH.CPHS, ATTACH.ED, ATTACH.GENERAL, ATTACH.GI, ATTACH.LAB, ATTACH.MEDS, ATTACH.MODIFIER, ATTACH.OBS, ATTACH.PERIODONTAL, ATTACH.REHAB, ATTACH.REHAB.ABUSE, ATTACH.REHAB.CARDIAC, ATTACH.REHAB.NURS, ATTACH.REHAB.OT, ATTACH.REHAB.PSYCH, ATTACH.REHAB.PT, ATTACH.REHAB.PULM, ATTACH.REHAB.RT, ATTACH.REHAB.SOCIAL, ATTACH.REHAB.SPEECH, ATTACH.RESP, BDYCRC.ATOM, BDYHGT.ATOM, BDYHGT.MOLEC, BDYSURF.ATOM, BDYTMP.ATOM, BDYTMP.MOLEC, BDYTMP.TIMED.MOLEC, BDYWGT.ATOM, BDYWGT.MOLEC, BLDBK, BP.ATOM,
BP.CENT.MOLEC, BP.MOLEC, BP.PSTN.MOLEC, BP.TIMED.MOLEC, BP.VENOUS.MOLEC, CARD.RISK, CARD.US, CARDIO-PULM, CLIN, DENTAL, DEVICES, DOC.ADMIN.LEGAL, DOC.CLINRPT, DOC.EPSOS, DOC.MISC,
DOC.QUALITY, DOC.REF, DOC.REF.CTP, DOCUMENT.REGULATORY, DRUGDOSE, ED, EKG.ATOM, EKG.IMP, EKG.MEAS, ENDO.GI, EYE, EYE.CONTACT_LENS, EYE.GLASSES, EYE.HETEROPHORIA, EYE.OCT, EYE.PX, EYE.REFRACTION, EYE.RETINAL_RX, EYE.TONOMETRY, EYE.US, EYE.VISUAL_FIELD, FUNCTION, GEN.US, H&P.HX, H&P.HX.LAB, H&P.PX, H&P.SURG PROC, HEMODYN.ATOM, HEMODYN.MOLEC, HRTRATE.ATOM, HRTRATE.MOLEC, HRTRATE.PSTN.MOLEC, HRTRATE.TIMED.MOL, IO.TUBE, IO_IN.ATOM, IO_IN.MOLEC, IO_IN.SUMMARY, IO_IN.TIMED.MOLEC, IO_IN_SALTS+CALS, IO_OUT.ATOM, IO_OUT.MOLEC, IO_OUT.TIMED.MOLE, MISC, MOLPATH.INV, NEMSIS, NEONAT, NR STATS, OB.US, OBGYN, PANEL.ART, PANEL.BDYTMP, PANEL.BP, PANEL.CARDIAC, PANEL.CLIN, PANEL.CV, PANEL.DOC, PANEL.DOC.CLINRPT, PANEL.ED, PANEL.EYE, PANEL.FUNCTION, PANEL.H&P, PANEL.IO, PANEL.NEMSIS, PANEL.NEONAT, PANEL.OB.US, PANEL.OBS, PANEL.PATIENT SAFETY, PANEL.PHENX, PANEL.PHR, PANEL.PULM, PANEL.RAD, PANEL.SURVEY.AHRQ, PANEL.SURVEY.BIMS, PANEL.SURVEY.CAM, PANEL.SURVEY.CARE, PANEL.SURVEY.CDC, PANEL.SURVEY.CMS, PANEL.SURVEY.EPDS, PANEL.SURVEY.ESRD, PANEL.SURVEY.GDS, PANEL.SURVEY.GNHLTH, PANEL.SURVEY.HHCC, PANEL.SURVEY.HHS, PANEL.SURVEY.HIV-SSC, PANEL.SURVEY.howRU, PANEL.SURVEY.LIV-HIV, PANEL.SURVEY.MDS, PANEL.SURVEY.MFS, PANEL.SURVEY.MTLHLTH, PANEL.SURVEY.NEURO, PANEL.SURVEY.NEUROQ, PANEL.SURVEY.NMMDS, PANEL.SURVEY.NORTON, PANEL.SURVEY.NSRAS, PANEL.SURVEY.OASIS, PANEL.SURVEY.OMAHA, PANEL.SURVEY.OPTIMAL, PANEL.SURVEY.PHQ, PANEL.SURVEY.PROMIS, PANEL.SURVEY.QAM, PANEL.SURVEY.QRDA, PANEL.SURVEY.RFC, PANEL.SURVEY.SAMHSA, PANEL.SURVEY.USSGFHT, PANEL.TIMP, PANEL.TUMRRGT, PANEL.US.URO, PANEL.VACCIN, PANEL.VITALS, PATH.PROTOCOLS.GENER, PATIENT SAFETY, PHENX, PUBLICHEALTH, PULM, RAD, RESP.ATOM, RESP.MOLEC, RESP.TIMED.MOLEC, SKNFLD.MOLEC, SPEC, SURVEY.AAOS, SURVEY.AHRQ, SURVEY.CARE, SURVEY.CDC, SURVEY.CERNER, SURVEY.EPDS, SURVEY.ESRD, SURVEY.GDS, SURVEY.GNHLTH, SURVEY.HHS, SURVEY.howRU, SURVEY.MDS, SURVEY.MFS, SURVEY.MISC, SURVEY.MTLHLTH, SURVEY.NEURO, SURVEY.NEUROQ, SURVEY.NMMDS, SURVEY.NORTON, SURVEY.NSRAS, SURVEY.NURSE.HHCC, SURVEY.NURSE.HIV-SSC, SURVEY.NURSE.LIV-HIV, SURVEY.NURSE.OMAHA, SURVEY.NURSE.QAM, SURVEY.OASIS, SURVEY.OPTIMAL, SURVEY.PHQ, SURVEY.PROMIS, SURVEY.QRDA, SURVEY.RFC, SURVEY.SAMHSA, SURVEY.USSGFHT, TIMP, TRAUMA, TRNSPLNT.ORGAN, TUMRRGT, US.URO, VACCIN, VOLUME.MOLEC

The above listed classes are not recognized.
Public Law, CFR Citation(s) and Procode(s)
21 CFR 862, 864, 866
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contacts
 Steven Gitterman
  FDA/OMPT/CDRH/OIR
  301-796-6694
  steven.gitterman@fda.hhs.gov
 Michael Waters
  FDA/OMPT/CDRH/OIR/DMD/BAC1/
  301-796-4653
  michael.waters@fda.hhs.gov
Standards Development Organization
RII Regenstrief Institute, Inc. http://www.regenstrief.org/
FDA Specialty Task Group (STG)
Software/Informatics
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