Employment Law Now VIII-150 - The FTC Noncompete Rule is Dead: What Now?
ERISA Blog | Changes to the HIPAA Privacy Rules A Primer for Self-Insured Group Health Plans
Sustainable Procurement: A Closer Look at the New Federal Acquisition Regulation (FAR)
Employment Law Now VIII-145 – Status Update: Injunctions for FTC Non-Compete Ban and DOL Overtime Exemption Regs
Legal Alert | Reign It In: Federal Court Enjoins DOL's Expansion of Davis-Bacon Coverage
Consumer Finance Monitor Podcast Episode: What Banking Leaders Need to Know About the U.S. Supreme Court Ruling That the CFPB’s Funding Mechanism is Constitutional Part I
Unpacking FERC's Transmission Planning and Permitting Final Rules
The Burr Broadcast: Key Differences Between PWFA and ADA
DOL’s Expanded Overtime Salary Limits, EEOC’s Sexual Harassment Guidance, NY’s Mandatory Paid Prenatal Leave - Employment Law This Week®
The FTC Issued a New Rule to Ban All New Noncompete Agreements
Preparing for Major Changes to DOT’s Disadvantaged Business Enterprise DBE Program
#WorkforceWednesday: FTC Nixes Non-Competes Nationwide—Now What? - Employment Law This Week® - Spilling Secrets Podcast
Fierce Competition Podcast | Understanding the FTC’s Landmark Ban on Noncompetes
Meeting the Proposed SEC Climate Disclosure Requirements
Consumer Finance Monitor Podcast Episode: A Close Look at the Consumer Financial Protection Bureau’s Final Credit Card Late Fee Rule: Have Cardholders Been Dealt a Winning or Losing Hand?
What's the Tea in L&E? Alert: Salary Threshold for Exempt Employees Increases to $58,656
What's the Tea in L&E? Alert: Non-Compete Agreements Largely Banned by New FTC Rule
#WorkforceWednesday: SCOTUS Expands Title VII, EEOC’s Final PWFA Rule, AI Screening Tools - Employment Law This Week®
The CFPB's Final Credit Card Late Fee Rule: Implications and Industry Response — The Consumer Finance Podcast and Payments Pros: The Payments Law Podcast
Successor Government Contractor Hiring Obligations Change: DOL’s Long Awaited Nondisplacement Rule
On August 19, 2024, the Association for Molecular Pathology (AMP) sued the FDA to challenge a new rule that allows the FDA to regulate laboratory developed tests (LDTs). The rule, which became effective on July 5, 2024,...more
The U.S. Food and Drug Administration (FDA) is reaffirming its plans to actively regulate certain laboratory developed tests (LDTs) that the FDA has historically treated with enforcement discretion. On June 25, 2024, the FDA...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed Tests." The final rule...more
On May 29, 2024, a lawsuit was filed in the U.S. District Court for the Eastern District of Texas, challenging the U.S. Food and Drug Administration’s final rule concerning the regulatory status of laboratory developed tests...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286) that will, over the next four years, radically alter the landscape for laboratory developed tests (LDTs). This action...more
On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) published its...more
This Week in Washington: House Ways and Means Committee marks up telehealth legislation; CMS extends state Medicaid unwinding flexibilities; Senate HELP Committee ranking member releases white paper outlining possible NIH...more
Our FDA/Food, Drug & Device Team analyzes the practical considerations for adhering to the Food and Drug Administration’s final rule for laboratory-developed tests (LDTs)....more
On May 6, 2024 the FDA published its much-anticipated Final Rule on Lab-Developed Tests (“LDTs”) to make explicit that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act (“FD&C...more
The U.S. Food and Drug Administration's (FDA) recent announcement of a final rule extending regulatory oversight to laboratory developed tests (LDTs) has sparked controversy. As discussed in a previous Holland & Knight alert,...more
On April 29, 2024, FDA finalized the long-awaited rule to assert authority over the regulation of laboratory developed tests (LDTs) under FDA’s existing regulatory framework for medical devices under the Federal Food, Drug,...more
On April 29, 2023, the FDA announced a final rule on regulation of laboratory developed tests (LDTs). The rule explicitly categorizes in vitro diagnostic products (IVDs) intended for clinical use as medical devices, which are...more
The U.S. Food and Drug Administration (FDA) issued a final rule on April 29, 2024, that significantly changes the regulatory framework for laboratory developed tests (LDTs). LDTs are in vitro diagnostic products (IVDs) that...more
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
On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...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
On February 2, 2024, FDA finalized its nearly two-year-long process to harmonize QS regulations with ISO standards. As we mentioned when FDA proposed the harmonization in 2022, this update represents the first update to the...more
On December 6, 2023, the Office of Information and Regulatory Affairs (“OIRA”) released the Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions (the “Agenda”), a semiannual compilation of information regarding...more
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
On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) finalized new policies related to remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) services reimbursed under the Medicare...more
Senators Focus Attention on Litigation Funding’s Opacity - Building on the momentum we previously noted related to litigation funding, on September 14, Senator John Kennedy introduced the Protecting Our Courts from Foreign...more