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
Abbott’s Alinity m MPXV assay for detecting DNA from the monkeypox virus received FDA EUA on Oct. 7.
Learn more about how Congress could change PAMA, why it matters to your lab, and how you can prepare.
The pandemic came with great pain and suffering for many, but it also allowed telehealth and other technologies to flourish.
Learn more about how leveraging data automation to get clean patient data at the front end can be a game changer for labs.
The CDRH Total Product Life Cycle Advisory Program Pilot aims to improve the FDA authorization process for medical devices.
The new deal provides the FDA a minimum of $1.78 billion in user fees from 2023 to 2027.
In this week’s enforcement roundup, Radeas reaches a settlement with the State of North Carolina after alleged improper billing.
Judge Edward Davila postponed sentencing for at least one month to consider new evidence of possible government misconduct.
Learn more about the legal remedies potentially available to clinical labs who have not been fully paid for COVID testing by insurers.
Learn about how the COVID-19 pandemic has shaped the clinical lab industry and how those lessons can lead to better labs for the future.