Laboratory Developed Test Regulatory Reform Moves Closer to Reality
Newly proposed legislation would establish a risk-based regulatory system for LDT regulation, though not everyone is happy with it.
Newly proposed legislation would establish a risk-based regulatory system for LDT regulation, though not everyone is happy with it.
For the first time, the FDA has granted emergency use authorization for a test to differentiate strains of the SARS-CoV-2 virus.
Effective June 1, the agency is once more accepting pre-submission requests for all in vitro diagnostics, including non-COVID-19 tests.
A glitch in the local run management software may open the door to hacking, agency says.
Senate committee members propose a modified version of legislation allowing the FDA to continue to regulate LDTs on a risk-tiered basis.