The obvious result of the legal shootout between the U.S. Food & Drug Administration (FDA) and clinical laboratory trade associations, the American Clinical Laboratory Association and the Association for Molecular Pathology,...more
4/11/2025
/ Appeals ,
CLIA ,
Clinical Laboratories ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Medical Devices ,
Regulatory Authority ,
Regulatory Requirements ,
Trump Administration
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more
3/14/2025
/ Clinical Laboratory Testing ,
Compliance ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Regulation ,
Regulatory Requirements ,
Risk Management
The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both existing and start-up, are...more
On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited Remanufacturing of Medical Devices Draft Guidance (Draft Remanufacturing Guidance), which describes the agency’s current thinking on activities...more
On March 25, 2020, the Food and Drug Administration (FDA) issued a temporary policy relating to enforcement of regulatory requirements for face masks and respirators during the COVID-19 crisis. Since the public health...more
On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following:
- Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act...more
10/10/2019
/ 21st Century Cures Act ,
CDS ,
Comment Period ,
Digital Health ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
International Medical Device Regulators Forum (IMDRF) ,
Medical Devices ,
Medical Software ,
Patients ,
Public Comment ,
Regulatory Requirements ,
Software Developers
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT for Patients and Communities Act”) – which is intended to combat the spread and pernicious...more
11/13/2018
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Health Care Providers ,
OIG ,
Opioid ,
Pain Management ,
Patient Referrals ,
Regulatory Oversight ,
Regulatory Requirements ,
Remuneration ,
Safe Harbors ,
Secretary of HHS
On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and recommendations on designing...more