For many device makers, the biggest commercial hurdle isn’t FDA authorization—it’s the long wait for Medicare to decide on coverage. Historically, the gap between FDA market authorization and a National Coverage Determination...more
In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more
7/17/2025
/ CLIA ,
Clinical Laboratories ,
Compliance ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Medical Devices ,
Medical Research ,
Regulatory Requirements
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved...more
As the Sunshine Act reporting deadline of March 31, 2024 draws near, medical device and pharmaceutical companies are gearing up for their Sunshine Act reporting.
Are you prepared for a Sunshine Act audit? Reporting...more
2/9/2024
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Reporting Requirements ,
Sunshine Act