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Gardner Law

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

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The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

Bergeson & Campbell, P.C.

PPG Withdraws TSCA Section 21 Petition to Amend Final TCE Risk Management Rule for Specialty Polymeric Microporous Sheet Materials...

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As reported in our May 13, 2025, blog item, on March 24, 2025, PPG Industries, Inc. (PPG) submitted a petition seeking an amendment to the U.S. Environmental Protection Agency’s (EPA) December 2024 final risk management rule...more

Holland & Knight LLP

EPA Extends TSCA Reporting Submission Deadline for 16 Substances

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The U.S. Environmental Protection Agency (EPA) finalized a rule to extend the deadline for manufacturers and importers of 16 chemicals to report certain unpublished health and safety studies to the EPA as required by a...more

Bergeson & Campbell, P.C.

ACC Files TSCA Section 21 Petition Seeking Reconsideration of TCE Risk Management Rule

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On May 27, 2025, the American Chemistry Council (ACC) petitioned the U.S. Environmental Protection Agency (EPA) under Section 21 of the Toxic Substances Control Act (TSCA) to reconsider the final risk management rule for...more

Bergeson & Campbell, P.C.

EPA Extends Deadline to Report Health and Safety Data for 16 Chemicals

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The U.S. Environmental Protection Agency (EPA) issued a final rule on June 9, 2025, that extends the reporting deadlines for a rule under Section 8(d) of the Toxic Substances Control Act (TSCA) requiring manufacturers...more

Bergeson & Campbell, P.C.

EPA Receives TSCA Section 21 Petitions Seeking Reconsideration of Exemption Conditions in Final Trichloroethylene Rule

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The U.S. Environmental Protection Agency (EPA) recently updated its website to include two petitions submitted under Section 21 of the Toxic Substances Control Act (TSCA) that seek reconsideration of exemption provisions of...more

Bergeson & Campbell, P.C.

EPA Will Extend Deadline for Reporting Health and Safety Data for 16 Chemicals

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The U.S. Environmental Protection Agency (EPA) announced on March 6, 2025, that it plans to issue a rule “soon” to extend the reporting deadline for a rule under Section 8(d) of the Toxic Substances Control Act (TSCA)...more

Bennett Jones LLP

Driving Compliance: Updates to Canada’s Motor Vehicle and Equipment Safety Regulations

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Regulations Amending Certain Regulations Made Under the Motor Vehicle Safety Act (Recall Information), SOR/2024-274 (Regulations) came into force on January 1, 2025.  The Regulations amend...more

Gardner Law

Streamlining Device Changes with Predetermined Change Control Plans (PCCPs)

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In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved...more

Downey Brand LLP

EPA Adds Extensive New Amendments to its Risk Management Program in Final Rule

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On March 11, 2014, the Environmental Protection Agency (EPA) published in the Federal Register amendments to the Risk Management Program (RMP) rule (Final Rule). Going into effect on May 10, 2024, EPA’s Final Rule, named the...more

Jones Day

FDA's Final Device Manufacturing Rule—Not Quite Harmonious With Status Quo

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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

Alston & Bird

EPA Finalizes Sweeping New Safety Standards and Public Disclosure Requirements for Chemical Accidents

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Our Environment, Land Use & Natural Resources Group examines the Safer Communities by Chemical Accident Prevention Rule’s stringent requirements for accident prevention, response, and public disclosure of information....more

Bergeson & Campbell, P.C.

EPA Bans Consumer Sales of Methylene Chloride Paint Removers, Seeks Comment on Program for Commercial Uses

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On March 15, 2019, the U.S. Environmental Protection Agency (EPA) published a signed final rule that prohibits the manufacture (including import), processing, and distribution of methylene chloride for consumer paint and...more

Jones Day

An Assessment and Comparison of New TSCA and REACH

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Passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, or "New Toxic Substances Control Act," introduces a number of changes to regulations for the collection and assessment of information concerning...more

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