the United States Government, United States Code — Title 42, Chapter 6a…
“ Prior to amendment, text read as follows: "The examinations and procedures identified in paragraph (2) are simple laboratory examinations and procedures which, as determined by the Secretary, have an insignificant risk of an erroneous result, including those which - " (A) have been approved by the Food and Drug Administration for home use, " (B) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible, or " (C) the Secretary has determined pose no reasonable risk of harm to the patient if performed incorrectly." ”
