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Comment Period Regulatory Requirements Manufacturers

Bergeson & Campbell, P.C.

Comments on Maine’s Proposed CUU Amendment Due September 2, 2025

The Maine Department of Environmental Protection (MDEP) began a public consultation on July 30, 2025, on a proposed amendment to Chapter 90: Products Containing Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS). The...more

Holland & Knight LLP

California's Microplastics Proposal: Impacts on the Consumer Products Supply Chain: The Proposed Listing of Microplastics Reflects...

Holland & Knight LLP on

California's Department of Toxic Substances Control (DTSC) has proposed listing microplastics on its "Candidate Chemicals List" under the Safer Consumer Products (SCP) Program, a regulatory framework designed to reduce toxic...more

Katten Muchin Rosenman LLP

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

Womble Bond Dickinson

FCC Proposes to Add Certain Connected Vehicle Technologies to the Covered List

Womble Bond Dickinson on

The Federal Communications Commission’s (FCC or Commission) Public Safety and Homeland Security Bureau (Bureau) and Office of Engineering and Technology (OET) have published a Public Notice seeking input on adding certain...more

Bergeson & Campbell, P.C.

Minnesota Extends Public Comment Period on Proposed PFAS Reporting Rule as Entities Voice Concerns about Compliance with Deadlines...

On May 22, 2025, the Minnesota Pollution Control Agency (MPCA) held a public hearing on its “Proposed Permanent Rules Relating to PFAS in Products; Reporting and Fees” (proposed rule). Administrative Law Judge (ALJ) Jim...more

Bergeson & Campbell, P.C.

Petitions Filed to Add Chemicals to List of Chemical Substances Subject to Superfund Excise Tax

On April 2 and April 3, 2025, the Internal Revenue Service (IRS) announced that petitions have been filed to add the following chemicals to the list of taxable substances...more

Burr & Forman

ADEM Proposes Revisions to its Recycling Rules – 15 Years in the Making

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After 15 years without significant revisions, the Alabama Department of Environmental Management (ADEM) is proposing an overhaul of its recycling rules.  The proposed regulations, which ADEM released for public notice and...more

DLA Piper

Maine DEP Proposes Currently Unavoidable Use Procedures for PFAS in Products Law

DLA Piper on

Maine’s Department of Environmental Protection (DEP) recently published a proposed rule prescribing procedures and criteria for determining Currently Unavoidable Uses (CUU) of intentionally added per- and polyfluoroalkyl...more

Foley Hoag LLP

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

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FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more

Perkins Coie

FDA Publishes Draft Guidance For Submitting Cosmetic Product Facility Registrations and Product Listings Under MoCRA

Perkins Coie on

The U.S. Food and Drug Administration (FDA) issued draft guidance on August 7, 2023, clarifying new requirements for cosmetic facility registrations and product listings under the Modernization of Cosmetics Regulation Act of...more

Snell & Wilmer

A Deeper Dive into FDA Draft Guidance on the Remanufacturing of Medical Devices

Snell & Wilmer on

In the medical device industry, there exists a longstanding divide between device manufacturers (i.e., those who design, manufacture, fabricate, or process a finished device) and the third-party entities that service the...more

Stinson LLP

FDA Proposes (Again) to Amend the "Intended Use" Regulation

Stinson LLP on

This week, FDA published a proposed rule that would amend its medical product "intended use" regulations, 21 CFR §§ 201.128 and 801.4 and replace the 2017 Final Rule about the same issue that never became effective....more

Hogan Lovells

EU Commission seeks feedback on implementing the new Market Surveillance Regulation

Hogan Lovells on

The European Commission announced on 22 January 2020 that it is looking for feedback on draft guidelines on the implementation of Article 4 of the Market Surveillance Regulation (EU) 2019/1020 (the "Regulation"). ...more

Seyfarth Shaw LLP

NDAttention – National Defense Authorization Act (NDAA) Adds Per- and Polyfluoroalkyl Chemicals to TRI

Seyfarth Shaw LLP on

Seyfarth Synopsis: On December 20, 2019, the National Defense Authorization Act for Fiscal Year 2020 (NDAA) was signed into law, including provisions for adding certain per- and polyfluoroalkyl substances (PFAS) to the EPA’s...more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spalding on

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

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Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more

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