
June 2023 FDA Watch
So far, it appears many post-PHE COVID-19 tests will be panels for detecting and differentiating among multiple respiratory viruses.
Diagnostic Testing and Emerging Technologies
LAB COMPLIANCE ADVISOR
LABORATORY INDUSTRY REPORT
NATIONAL LAB REPORTER
So far, it appears many post-PHE COVID-19 tests will be panels for detecting and differentiating among multiple respiratory viruses.
The bill is designed to provide Medicare patients faster access to innovative technology approved by the FDA.
HHS secretary takes action to ensure that EUAs remain in effect until the “significant potential” for a COVID-19 PHE no longer exists.
Companies in the COVID-19 diagnostic products market will need to decide whether to wind down their EUA-based investments.
Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.