• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • 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 038 Date of Entry 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*
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
 Steven Gitterman
  FDA/OMPT/CDRH/OIR
  301-796-6694
  steven.gitterman@fda.hhs.gov
Standards Development Organization
RII Regenstrief Institute, Inc. http://www.regenstrief.org/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
-
-