The Food and Drug Administration released a final rule Sept. 18 that rescinds one from 2024 that applied medical device rules ...
The U.S. Food and Drug Administration will rescind a rule that tightened regulations for clinical laboratories and gave the ...
The FDA has scrapped a rule that would have allowed the agency to regulate lab-developed tests as medical devices. Under the rule, the FDA would have phased in oversight of laboratory-developed tests ...