7 ways to challenge FDA’s regulation of LDTs

The FDA's announcement of its intention to regulate Lab Developed Tests (LDTs) in line with medical device regulations has sparked concerns among developers, anticipating significant financial implications. We provide a comprehensive overview of seven strategic approaches for LDT developers to challenge the FDA's regulatory proposal. Firstly, leveraging the public comment period,Participating in Part 15 hearings provide direct avenues to voice concerns and influence final regulation...