| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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038
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Date of Entry 01/27/2015
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FR Recognition Number
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13-71
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| Standard | |
RII Version 2.48
Logical Observation Identifiers Names and Codes (LOINC) |
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
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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. |
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| FDA Technical Contact
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| Standards Development Organization
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FDA Specialty Task Groups (STG)
| Software/Informatics (primary) |
| InVitro Diagnostics |
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| *These are provided as examples and others may be applicable. |
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