On March 31, 2025, the US District Court for the Eastern District of Texas struck down the US Food and Drug Administration’s (FDA) final rule under which FDA would have started regulating most laboratory-developed tests...more
In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities,...more
On October 10, 2024, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced its agenda of proposed guidance documents to be published or developed in the 2025 fiscal year (FY)....more
The US Supreme Court has overruled the longstanding Chevron doctrine, an administrative law doctrine that required courts to defer to reasonable agency interpretations of ambiguous statutes. Loper Bright Enterprises v....more
7/5/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Chevron v NRDC ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Judicial Authority ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Statutory Interpretation
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
6/20/2024
/ Artificial Intelligence ,
Biologics ,
Cannabis Products ,
Clinical Trials ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Legislative Agendas ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Medical Marijuana ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology
In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare...more
11/15/2023
/ American Medical Association ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Data Collection ,
Durable Medical Equipment ,
Final Rules ,
Food and Drug Administration (FDA) ,
FQHC ,
Health Care Providers ,
Health Technology ,
Healthcare ,
Medical Billing Codes ,
Medical Devices ,
Medical Monitoring ,
Medicare ,
Mental Health ,
Payment Systems ,
Physician Fee Schedule ,
Public Health Emergency ,
Reimbursements
On September 29, 2023, the US Food and Drug Administration (FDA) published a long-awaited proposed rule on laboratory-developed tests (LDTs). If FDA finalizes this rule as proposed, FDA will regulate virtually all LDTs as...more
On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a procedural notice with comment period on Transitional Coverage for Emerging Technologies (TCET), a new pathway that uses existing national coverage...more
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
2/6/2023
/ Biologics ,
Clinical Laboratory Testing ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Legislative Agendas ,
Manufacturers ,
Medical Devices ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Requirements ,
Safety Inspections ,
Supply Chain
+Dx Forum 2023 is the premier gathering for the laboratory diagnostics community.
Join us for insightful discussion about the latest regulatory and reimbursement developments....more
2/1/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Diagnostic Tests ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Reform ,
Laboratory Developed Tests ,
Legislative Agendas ,
Medicare Administrative Contractors (MAC) ,
Prior Authorization ,
Regulatory Agenda ,
Reimbursements
On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more
11/1/2021
/ Artificial Intelligence ,
Food and Drug Administration (FDA) ,
Health Canada ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Medical Software ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Guidance ,
Popular ,
Public Comment ,
Software Developers ,
UK
Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community.
Gain insight into how the industry addresses regulatory and business...more
3/18/2021
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Enforcement Actions ,
Evidence ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Legislative Agendas ,
Life Sciences ,
Medicare ,
Medicare Administrative Contractors (MAC) ,
Physicians ,
Regulatory Oversight ,
Scientific Research ,
Stark Law ,
Vaccinations ,
Webinars
On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding “Intended Uses” proposed rule (Proposed Rule) to amend its “intended use” regulations at 21 C.F.R. §§ 201.128 and 801.4. The...more
9/28/2020
/ Comment Period ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
Labeling ,
Motion for Reconsideration ,
Motion To Stay ,
Off-Label Use ,
Proposed Rules ,
Public Health Service Act ,
Repeal
When the academic year ended in the spring of 2020, many US university students assumed that a return to campus would be straightforward this fall. However, it is now clear—at least in the near term—that a return to the old...more
8/27/2020
/ CLIA ,
Consent Agreements ,
Contact Tracing ,
Educational Institutions ,
Emergency Use Authorization (EUA) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Mobile Apps ,
Quarantine ,
Re-Opening Guidelines ,
Remote Learning ,
Research and Development ,
Sanctions ,
Screening Procedures ,
Universities ,
Virus Testing ,
Waivers
The Coronavirus (COVID-19) pandemic poses an acute health risk to the population. One key to successfully combating COVID-19 lies in clinical research. Currently, almost all major research-based pharmaceutical companies, many...more
The Food and Drug Administration issued an enforcement policy on the use of digital health devices that are considered therapeutic for psychiatric disorders during the Coronavirus (COVID-19) public health emergency. The...more
On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, into law in response to the COVID-19 pandemic. Among other healthcare-related provisions, the CARES Act addresses...more
On March 26, 2020, the US Food and Drug Administration issued FAQs on 3D printing of medical devices, accessories, components and parts during the Coronavirus (COVID-19) pandemic. While the use of 3D printers can help address...more
As part of its initiatives to expedite access to investigational drugs or biologics for the treatment of Coronavirus (COVID-19), on March 24, 2020, the US Food and Drug Administration announced that healthcare providers may...more
The US Food and Drug Administration (FDA) announced several initiatives to increase access to ventilators and other respiratory devices during the Coronavirus (COVID-19) pandemic, as well as relaxed enforcement of certain...more
The Coronavirus (COVID-19) pandemic presents significant challenges for clinical trial sponsors. The US Food and Drug Administration issued guidance on March 19, 2020, that provides greater flexibility to adjust clinical...more
On March 20, 2020, the US Food and Drug Administration announced updates to its enforcement policy on the use of non-invasive remote monitoring devices, specifically for uses designed to support patient monitoring during the...more
On March 16, 2020, the US Food and Drug Administration (FDA) announced several initiatives intended to further increase access to validated COVID-19 testing. This alert addresses key components of the announcement, which...more
In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more
3/13/2020
/ Appropriations Bill ,
Biologics ,
China ,
Congressional Investigations & Hearings ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Emergency Response ,
Expedited Approval Process ,
Food and Drug Administration (FDA) ,
Medical Devices ,
National Institute of Allergy and Infectious Diseases (NIAID) ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Risk Management ,
Risk Mitigation ,
Supply Chain ,
Vaccinations
Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...more
1/29/2020
/ Anti-Kickback Statute ,
Biometric Information ,
California Consumer Privacy Act (CCPA) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Regulatory Standards ,
Stark Law ,
Telemedicine