On November 15, the U.S. Department of Health and Human Services (HHS) withdrew a controversial Trump-era HHS Policy Change that effectively prevented the Food and Drug Administration (FDA) from reviewing laboratory-developed...more
The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The SARS-CoV-2 virus has mutated over time,...more
2/25/2021
/ Coronavirus/COVID-19 ,
Diagnostic Tests ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Product Labels ,
Public Health Emergency ,
Research and Development ,
Virus Testing
On August 19, 2020, the U.S. Department of Health and Human Services (HHS) announced the rescission of guidances and other Food and Drug Administration (FDA) issuances concerning premarket review of Laboratory Developed Tests...more
U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability and utilization of...more
3/30/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Legislative Agendas ,
Proposed Legislation ,
Public Health Service Act ,
Regulatory Oversight
On April 4, 2019, the U.S. Food and Drug Administration's (FDA or the agency) Office of In Vitro Diagnostics and Radiological Health issued a Warning Letter to Inova Genomics Laboratory in one of the first FDA enforcement...more