3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
The latest regulatory, legal, compliance, and technology news for labs and pathology practices.
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
Lucira has fallen on hard times since it secured the first FDA EUA for an at-home COVID-19 test in November 2020.
Congress brings back controversial Trump plan scrapped by the Biden administration.
Although the law officially took effect on March 29, the FDA says it isn’t planning to enforce the new rules until October 1.
In the latest major COVID-19-related enforcement action, 18 individuals were charged in various schemes worth more than $490 million.
COVID-19 test makers will either have to get full marketing approval, or take the product off the market.
Labs must use the new Advance Beneficiary Notice of Noncoverage (ABN) form starting on June 30, 2023, when the old version expires.
Last week’s lone lab-related enforcement action involved a prison sentence for a woman posing as a licensed physician’s assistant.
The DOJ's 2022 Fraud Statistics Overview shows it raked in less than 50 percent of what it recovered in FY 2021.
Recent case shows that toxicology labs and drug testing remain a primary target for federal enforcement agencies.
Group of 18 senators says ending Medicare coverage for at-home COVID-19 tests would undo efforts to contain spread of the coronavirus.