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Manufacturers New Regulations

McDermott Will & Schulte

MHRA announces changes to international reliance and in vitro diagnostic devices rules

In late July 2025, the UK government published its response to a consultation held between November 2024 and January 2025 about international reliance, UK Conformity Assessed (UKCA) marking and in vitro diagnostic devices. In...more

BCLP

PFAS in Consumer Products: State-by-State Regulations - September 2025

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Manufacturers, distributors, and retailers of consumer products across a broad spectrum of industries are being impacted by state laws regulating the presence of per- and polyfluoroalkyl substances (“PFAS”) in their products....more

BakerHostetler

FDA’s ‘PreCheck’ Program: New Pathway to Acceleration of US Drug Manufacturing

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The U.S. Food and Drug Administration (FDA) has announced FDA “PreCheck,” a new regulatory program intended to streamline the development and approval of domestic pharmaceutical manufacturing facilities. ...more

Hogan Lovells

Key takeaways – UK MHRA’s response to consultation on ‘Medical Devices Regulations: Routes to market and in vitro diagnostic...

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more

Holland & Knight LLP

A MOSAIC of Changes: Recent FAA Actions Promote Advanced Air Mobility

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At the Experimental Aircraft Association's (EAA) annual EAA AirVenture Oshkosh, Wisconsin, on July 22, 2025, U.S. Department of Transportation Secretary Sean Duffy and Federal Aviation Administration (FAA) Deputy...more

DLA Piper

FAA Issues Final MOSAIC Rule: Key Updates and Changes

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The Federal Aviation Administration (FAA) released an unpublished version of the Modernization of Special Airworthiness Certification (MOSAIC) rule on July 22, 2025.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

Gardner Law

FDA Signals Interest in Defining Ultraprocessed Foods

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In June 2025, the U.S. Food and Drug Administration announced it is evaluating whether to formally define the term ultraprocessed food (UPF)—a move that could influence future labeling regulations, public health guidance, and...more

Stikeman Elliott LLP

Consumer Protection in Québec: A New Regulation Clarifies Requirements Relating to Availability of Replacement Parts and Repair...

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On June 25, 2025, the Government of Québec published a Regulation that clarifies the obligations of merchants and manufacturers with respect to the warranty of availability of replacement parts and repair services. These...more

Bergeson & Campbell, P.C.

MDEP Receives 11 CUU Proposals for Products Containing Intentionally Added PFAS Scheduled for Prohibition in 2026, Recommends Two...

As reported in our April 11, 2025, blog item, applications for currently unavoidable use determinations for products containing intentionally added perfluoroalkyl and polyfluoroalkyl substances (PFAS) and scheduled to be...more

Hogan Lovells

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

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The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

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In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more

Littler

OSHA Renews its National Emphasis Program on Amputations in the Manufacturing Industry

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The U.S. Department of Labor’s Occupational Safety and Health Administration renewed its National Emphasis Program on Amputations in Manufacturing Industries (NEP) on June 27, 2025, superseding the prior version. This new NEP...more

Kilpatrick

Minnesota's Extended Producer Responsibility (EPR) Law: Key Registration Deadline is July 1, 2025; Specifically Includes Boat Wrap...

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Minnesota was the fifth state to enact an Extended Producer Responsibility (“EPR”) law, following California, Colorado, Oregon, and Maine. Sharing many foundational principles with the EPR laws in these other states, your...more

Holland & Knight LLP

Chemical Ban Set to Hit Fashion Supply Chains in 2026

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In accordance with a final rule (the 2024 Rule) published by the U.S. Environmental Protection Agency (EPA) in late 2024, fashion-related articles containing phenol, isopropylated phosphate (PIP (3:1)) will be prohibited from...more

Hogan Lovells

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

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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

Holland & Hart LLP

The July 1 Deadline Approaches for Participation in the Colorado Extended Producer Responsibility (EPR) Program

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Beginning July 1, 2025, producers of a wide range of packaging and paper materials, as well as products that use such materials, are prohibited from selling or distributing such products in the state of Colorado, unless they...more

Akin Gump Strauss Hauer & Feld LLP

Minnesota to Delay PFAS Reporting Deadline

Earlier this week, the Minnesota Pollution Control Agency (MPCA) announced it will extend the upcoming reporting deadline under the state’s PFAS-in-Products law. As currently written, the law requires manufacturers of...more

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

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In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

PilieroMazza PLLC

New Developments for SBA’s HUBZone Program

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The U.S. Small Business Administration’s (SBA) Historically Underutilized Business Zone (HUBZone) program underwent a major rule change in January 2025, as we wrote about here. In this blog, PilieroMazza examines new...more

Wiley Rein LLP

ATF Allows Importation of Dual-Use Firearm Barrels, Irrespective of Previous Status or Configuration

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The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) has issued Ruling 2025-1, which loosens ATF’s policy with respect to the importation of firearm barrels. Specifically, the agency will now allow the importation of...more

Ballard Spahr LLP

Compliance With State Packaging Extended Producer Responsibility Laws Due by July 1, 2025

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Producers of packaging and other covered products are facing near-term deadlines to pay fees or register for programs intended to subsidize recycling in many states. With an initial fee payment due on July 1, 2025, for more...more

Sheppard Mullin Richter & Hampton LLP

Oregon Extends Privacy Law to Specifically List Auto Makers

In ongoing tweaks to state privacy laws, Oregon has amended its state privacy law to cover auto manufacturers. Specifically, those that process or control personal information that they get from a person’s use of a car... ...more

Hogan Lovells

Be vigilant: new post-market surveillance requirements for medical devices in Great Britain take effect

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The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (PMSR), which were passed into law on 22 October 2024, came into force today (16 June 2025), amending the UK’s Medical...more

Benesch

InterConnect Newsletter - Q2 2025

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The Federal Motor Carrier Safety Administration (FMCSA) issued an internal agency enforcement policy on May 20, 2025 (the Policy), outlining its approach to English language proficiency (ELP) for commercial motor vehicle...more

Bergeson & Campbell, P.C.

Chemical Product Law and Supply: A Guide to New TSCA

Hello, this is Lynn Bergeson. As many of our listeners may know, we here at Bergeson & Campbell, P.C. recently published a book through the American Bar Association’s Section of Environment, Energy, and Resources, titled...more

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