The full scope of the cuts remains unclear. Neither HHS nor the White House, CMS, CDC nor FDA responded to requests for comment on Sunday. The notices were contained in emails with the subject ...

Roche announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat sexually transmitted ...

1 FDA CLIA-waived tests broaden access to accurate, easy-to-use diagnostics for all patients in decentralized settings like urgent care centers, retail clinics, and community health venues.

More than 1 million curable sexually transmitted infections (STIs) are acquired every day worldwide in people 15–49 years old, most of which are asymptomatic. 1 FDA CLIA-waived tests broaden access to ...