RE: Just bought in3 Sep 2020 14:13
Repost of change in guidance regarding lab testing circa Aug 20th:
“ the department has determined that the Food and Drug Administration ("FDA") will not require premarket review of laboratory developed tests ("LDT") absent notice-and-comment rulemaking, as opposed to through guidance documents, compliance manuals, website statements, or other informal issuances. Those seeking approval or clearance of, or an emergency use authorization ("EUA") for an LDT may nonetheless voluntarily submit a premarket approval application, premarket notification or an EUA request, respectively, but are not required to do so, and FDA will adjudicate those submissions. Those opting to use LDTs in their laboratories without FDA premarket review or authorization may do so with the understanding that they would not be eligible for PREP Act coverage absent approval”
Not a lawyer but appear firms would lose element of immunity from liability - so again, without professing to know litigious ins/outs, would expect FDA EUA still required / preferable. But clearly optionality available if big pharma got comfortable with risk....
https://www.hhs.gov/coronavirus/testing/recission-guidances-informal-issuances-premarket-review-lab-tests/index.html