Latest KFF Health News Content

Latest KFF Health News Stories

Labs Developing Medical Tests Will Now Face Some FDA Scrutiny

Morning Briefing

Historically, such tests escaped federal regulation because they were considered low risk. But after the Theranos debacle, and as lab-developed tests become more complex and test for important things like genetic conditions, the FDA will start regulating them more. About 12,000 labs are affected, and legal action challenging the change is expected.