A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or overlooked merely because...more
Now that the final rule on laboratory developed tests (LDTs) has been available for over a month and the stages of the enforcement discretion phaseout process and the Food and Drug Administration’s (FDA’s) newly proposed...more
7/11/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
CLIA ,
Enforcement ,
Final Rules ,
Food and Drug Administration (FDA) ,
Judicial Review ,
Laboratory Developed Tests ,
Loper Bright Enterprises v Raimondo ,
Statutory Interpretation ,
Training
Receiving a warning letter from the U.S. Food and Drug Administration (FDA) means that the agency has identified what it calls “violations of regulatory significance” and that you (as the recipient) need to take corrective...more
As the COVID-19 public health emergency drags into its third year, we continue to keep track of efforts by the Food and Drug Administration (FDA) to combat fraud in the form of fake cures, counterfeit diagnostic tests, and...more
We recently published a post describing FDA’s recent actions to roll back enforcement policies implemented in response to the COVID-19 pandemic. On December 22, 2021, FDA took another step in that process by publishing...more