Sec. 544. State testing report
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/bill/116/hr/925/eah/section-544A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
For any State that authorizes (or intends to authorize) one or more laboratories in the State to develop and perform in vitro diagnostic COVID–19 tests, the head of the department or agency of such State with primary responsibility for health shall— notify the Secretary of such authorization (or intention to authorize); and provide the Secretary with a weekly report— identifying all laboratories authorized (or intended to be authorized) by the State to develop and perform in vitro diagnostic COVID–19 tests; including relevant information on all laboratories identified pursuant to subparagraph (A), which may include information on laboratory testing capacity; identifying all in vitro diagnostic COVID–19 tests developed and approved for clinical use in laboratories identified pursuant to subparagraph (A); and including relevant information on all tests identified pursuant to subparagraph (C), which may include— the name and contact information of the developer of any such test; any fact sheets, manufacturer instructions, and package inserts for any such test, including information on intended use; and the sensitivity and specificity of any such test.