Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 243: HIPAA Compliance and Potential Changes with Shannon Lipham of Maynard Nexsen
Aligning Business Goals with Legal Strategies Amid Regulatory Change – Speaking of Litigation Video Podcast
Predictions regarding the 2023 CRA Rule and Section 1071 and how to prepare for expected developments
Early Days of the Trump Administration: Impact on the CFPB — The Consumer Finance Podcast
2024 Payments Year in Review: CFPB and FTC Regulatory Trends – Part Two — Payments Pros – The Payments Law Podcast
FCRA Regulatory Year in Review — FCRA Focus Podcast
The Congressional Review Act – A Critical Tool for the New Administration
#WorkforceWednesday®: NLRB’s Expanding Power - Pushback and Legal Challenges Ahead - Employment Law This Week®
Cannabis Law Now Podcast: What’s Next for Schedule III Marijuana
Consumer Finance Monitor Podcast Episode: Reasons Why the CFPB Should Deny the Petition for Rulemaking on Post-Dispute Consumer Arbitration Agreements
AD Nauseam: Junk Fees Will Keep Us Together
CFPB's Rulemaking Under the FCRA (Part 3) – Crossover Episode With FCRA Focus Podcast
PLI's inSecurities Podcast - The Dangers of Regulation by Enforcement
CFPB's Rulemaking Under the FCRA – Crossover Episode With FCRA Focus Podcast - The Consumer Finance Podcast
CFPB's Larger Participant Rule for Consumer Payments - The Consumer Finance Podcast
Quick Takeaways From the 2024 Proposed Hospice Wage Index Rule
State AG Pulse | State AGs and Feds: The Dynamics of Influence & Collaboration
New Trends in How the CFPB Gathers Information - The Consumer Finance Podcast
State AG Pulse | Attorneys General as State Policymakers: The NY Model
Paredes on SEC Policies & Priorities
The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more
Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance...more
As the song goes, the Food and Drug Administration’s (“FDA’s”) 2024 Final Rule regulating laboratory-developed tests (“LDTs”) as medical devices (“Final Rule”), is not merely dead—it’s really most sincerely dead....more
Over the weekend, the Department of Justice (DOJ) did not file an appeal of the U.S. District Court for the Eastern District of Texas’ decision to vacate and set aside the agency’s final rule on the regulation of laboratory...more
CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more
On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written...more
As discussed in our May 6, 2024, Client Alert, earlier this year FDA issued its Final Rule for the regulation of laboratory-developed tests (LDTs) that the FDA has historically treated with enforcement discretion. A week...more
Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more
After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820 with the internationally accepted standard for...more
On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more
The Centers for Medicare & Medicaid Services (CMS) recently issued a long-awaited Notice with Comment Period outlining a proposed Transitional Coverage for Emerging Technologies (TCET) pathway under Medicare that would be...more
As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more
On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good manufacturing practice...more
Our team wanted to highlight a proposed rule issued by the U.S. Department of Health and Human Services (HHS) on 4 November 2020 - with only a 30-day comment period - that would establish sunset (expiration) dates for...more
Increased premarket submission and post-market reporting requirements potentially on the horizon for high-tech devices. The Food and Drug Administration’s (“FDA’s”) budget proposal for FY2021 telegraphs FDA’s plan to seek new...more
The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." ...more
On 2 July 2019 the U.S. Food and Drug Administration (FDA) issued a final rule finalizing the category of "517A decisions," previously termed "significant decisions," as well as two accompanying guidance documents related to...more
In a welcome move, on 1 April 2019 the U.S. Food and Drug Administration (FDA) proposed reducing regulatory requirements for a number of radiation-emitting electronic products, including radiation-emitting medical devices. ...more
From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more
As an update to my post on Friday, April 22, FDA has extended the deadline for comments on third-party servicing of medical devices. According to FDA’s notice of extension, comments are now due by June 3, 2016....more
Additional guidance documents are expected. The US Food and Drug Administration’s (FDA’s) first quarter of calendar-year 2016 has been a busy one on the medical device front. FDA’s Center for Devices and Radiological...more