News & Analysis as of

Manufacturers Compliance

Shook, Hardy & Bacon L.L.P.

Material Concerns: Legal Updates on Substances of Emerging Concern

First effective in 2024, the Act bans the sale or distribution of various products that contain intentionally added PFAS chemicals. On January 1, 2026, as part of the product phase-out timeline, the new law bans the sale or...more

DLA Piper

Producer Obligations Under EPR Laws: Exploring Alternatives to PRO Participation

DLA Piper on

A defining feature of the extended producer responsibility (EPR) laws emerging across the United States is the expectation that producers join a statewide producer responsibility organization (PRO). But for some producers,...more

Farella Braun + Martel LLP

The Proposition 65 Compliance Deadline for Vinyl Acetate is Fast Approaching

Starting on Jan. 3, 2026, warning requirements for vinyl acetate can be enforced under California’s Proposition 65, which is commonly referred to as “Prop 65.” The California agency charged with implementing Prop 65, the...more

ArentFox Schiff

Medicare 2026 Proposed Rules, Major Drug Pricing Updates, and What Stakeholders Need to Know

ArentFox Schiff on

Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These...more

DLA Piper

FAA Issues Final MOSAIC Rule: Key Updates and Changes

DLA Piper on

The Federal Aviation Administration (FAA) released an unpublished version of the Modernization of Special Airworthiness Certification (MOSAIC) rule on July 22, 2025. The rule will become effective 90 days after publication in...more

Bergeson & Campbell, P.C.

Prop 65 “Short Form” Warning Requirements — A Conversation with Lisa R. Burchi

This week, I sat down with Lisa R. Burchi, Of Counsel to Bergeson & Campbell, P.C. and resident expert on Proposition 65, among many other chemical laws. Lisa explains why businesses doing business in California need to know...more

Gardner Law

The Value of MDUFA

Gardner Law on

Anyone who has submitted a medical device for pre-market review knows the financial investment it takes to for FDA to conduct its review. Under the Medical Device User Fee Amendments (MDUFA), certain submissions, including...more

White & Case LLP

New EU Responsibility and Liability Landscape for Smart Medical Devices in a Global Context

White & Case LLP on

Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more

Cozen O'Connor

The State AG Report – 07.17.2025

Cozen O'Connor on

Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Democratic AGs Oppose Washing Away Appliance Efficiency...more

Gardner Law

Change Control Pitfalls: Legal & Regulatory Risks in FDA-Regulated Industries

Gardner Law on

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more

Foley & Lardner LLP

Episode 36: Let’s Talk Compliance: The Risks and Pitfalls of Health Care Supply Chain Compliance

Foley & Lardner LLP on

In this episode, Monica Chmielewski, vice chair of Foley’s Health Care Practice Group and Shannon Sumner, Chief Compliance Officer and Nashville’s Office Managing Principal of PYA explore how supply chain compliance is...more

Wiley Rein LLP

Wiley Consumer Protection Download (July 15, 2025)

Wiley Rein LLP on

FTC Sends Warning Letters Regarding Potential Noncompliance With “Made in USA” Requirements. On July 8, the FTC sent letters to a flagpole retailer, footwear maker, football equipment company, and personal care products...more

Kelley Drye & Warren LLP

Reminder: Federal Communications Commission – July and August Filings - 2025

Manufacturers of wireless handsets that are used in the delivery of digital commercial mobile radio service within the scope of FCC Rule 20.19 are required to file information annually regarding their compliance with the...more

McGlinchey Stafford

EPA Grants Two-Year Extension on Coke Oven Air Toxics Compliance Following Industry Input

McGlinchey Stafford on

The U.S. Environmental Protection Agency (EPA) has officially extended key compliance deadlines for air toxics standards affecting steel-sector coke oven operations, reflecting industry concerns about the feasibility of...more

EPR Group Consulting Inc.

EPR Programs: What About B2B Packaging?

There is consternation among some industries that extended producer responsibility (EPR) programs for packaging in the United States include business-to-business (B2B) packaging – and thus may compromise the specialized reuse...more

Davis Wright Tremaine LLP

European Accessibility Act Goes Live

As of June 28, 2025, enforcement of the European Accessibility Act (EAA or the Act) can officially begin, marking a significant milestone for digital accessibility in the European Union (EU). The EAA establishes comprehensive...more

Epstein Becker & Green

New OIG Advisory Opinion Approves Manufacturer’s Warranty for Injuries Caused by Medical Device

Epstein Becker & Green on

On June 30, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services posted Advisory Opinion 25-05 (AO 25-05) to its website....more

Mintz - Health Care Viewpoints

Health Law Diagnosed – Best Practices for Communicating with the FDA

In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA....more

Mintz

[Podcast] Health Law Diagnosed – Best Practices for Communicating with the FDA

Mintz on

In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA. Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more

Skadden, Arps, Slate, Meagher & Flom LLP

OIG Issues Unfavorable Advisory Opinion: Provision of Free Services to Referral Sources Creates Kickback Risk

Key Points - - The Office of Inspector General of the Department of Health and Human Services (OIG) has issued Advisory Opinion No. 25-04 (AO 25-04), its first advisory opinion of the year addressing a proposed arrangement...more

ArentFox Schiff

FDA’s Remote Regulatory Assessments Enhance DSCSA Compliance With Technology-Driven Oversight

ArentFox Schiff on

On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more

Gardner Law

What to Do When FDA Detains Your Shipment

Gardner Law on

When products in your shipment violate—or appear to violate—FDA laws and regulations, the FDA may detain your product and issue a Notice of FDA Action with the designation of “Detained.” This notice is considered the Notice...more

Hogan Lovells

The path to circularity - Navigating through the EU’s sustainable product regulations on batteries, deforestation, ecodesign,...

Hogan Lovells on

The European Commission's new efforts to boost the EU's competitiveness through the Clean Industrial Deal and sweeping regulatory simplification have garnered significant attention. At the same time, circularity remains a...more

Morrison & Foerster LLP

German Accessibility Act Comes into Force

Individuals with disabilities face numerous challenges when accessing digital services and products, encountering significant barriers in their daily lives. The German Accessibility Act (Barrierefreiheitsstärkungsgesetz,...more

King & Spalding

EUROPE - Navigating the Interplay Between EU AI Act and Medical Device Regulations: Strategic Update for the Healthcare Sectors

King & Spalding on

Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a horizontal legal instrument...more

236 Results
 / 
View per page
Page: of 10

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide