The U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaited final rule that laboratory developed tests (LDTs) will be regulated as medical devices....more
The U.S. Food and Drug Administration (FDA) recently announced its plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical devices that have been marketed under special...more
The U.S. Food and Drug Administration (FDA) has officially launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH) to expand the agency's activities in furtherance of its...more
In struggling to address the evolving COVID-19 pandemic, the United States and many other countries continue to face major shortages of Personal Protective Equipment (PPE), such as N95 masks, gowns and other vital materials...more
8/3/2020
/ Bank Secrecy Act ,
Coronavirus/COVID-19 ,
Customs and Border Protection ,
Department of Justice (DOJ) ,
Enforcement Actions ,
FinCEN ,
Fraud ,
Imports ,
Medical Devices ,
Medical Supplies ,
Personal Protective Equipment ,
Price Gouging ,
Scams ,
Supply Chain
The U.S. Food and Drug Administration (FDA) has issued several final guidance documents to assist manufacturers developing medical products in response to the coronavirus (COVID-19) pandemic. While some are published as...more
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On January 25, President Trump announced that the White House and congressional leaders in the House and Senate have reached an agreement to fund the government on a short-term continuing resolution (CR) through Feb....more
1/25/2019
/ Abbreviated New Drug Application (ANDA) ,
Agricultural Sector ,
Appropriations Bill ,
Continuing Resolution ,
Department of Health and Human Services (HHS) ,
Drug Approvals ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Medical Devices ,
Popular
On Dec. 8, 2017, the FDA issued draft guidance detailing its regulatory approach to Clinical Decision Support (CDS) technology. For years, software manufacturers developing products intended for use by health care providers...more
12/12/2017
/ 21st Century Cures Act ,
CDS ,
Comment Period ,
Digital Health ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
Medical Software ,
Patients ,
Public Comment ,
Software Developers ,
Technology Sector
The Food and Drug Administration (FDA) continues to flesh out its ideas for regulation of digital health. Last week, the agency published a notice in the Federal Register, announcing a pilot program to evaluate a “new...more
In an action that will have broad implications for drug and device manufacturers, researchers, distributors, teaching hospitals and physicians, on February 1, the Centers for Medicare and Medicaid Services (CMS) publicly...more
2/5/2013
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Continuing Medical Education ,
Enforcement ,
Exclusions ,
Medicaid ,
Medical Devices ,
Medical Research ,
Medicare ,
Payment Records ,
Penalties ,
Pharmaceutical Industry ,
Physicians ,
Reporting Requirements ,
Sunshine Act ,
Vendors