LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
A look at the US end-of-emergency game plan and how it will impact lab compliance.
The year was certainly an interesting one in terms of regulatory change in the medical laboratory space.
After the price transparency rules took effect in January 2021, CMS finally issued the first penalties for violations.
CMS recently announced some important changes affecting PAMA price reporting, along with a list of 17 new PLA codes that will be recognized.