Responding to increased public and congressional criticism of its arguably too-flexible approach to regulatory oversight of serological tests used to detect COVID-19 antibodies, on May 4, 2020, the Food and Drug...more
Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more
10/23/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Certificates of Compliance ,
Civil Monetary Penalty ,
CLIA ,
Clinical Laboratory Testing ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Food and Drug Administration (FDA) ,
Healthcare ,
Hospitals ,
Laboratories ,
Laboratory Developed Tests ,
Medicaid ,
Medicare ,
Sanctions