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Gardner Law

Why Every Manufacturer Needs a Robust Information Security Program

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Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more

Hogan Lovells

Securing supply in disruptive times – Ways to set up and adapt strategic sourcing agreements

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Driven by transformation trends and geopolitical volatilities, companies must reshape their sourcing strategies. Across all manufacturing sectors the focus is shifting towards securing access to vital technologies and scarce...more

BakerHostetler

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Industry Perspective

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Supply chain disruptions have become a significant challenge for the U.S. FDA-regulated products industry, affecting the availability of pharmaceuticals, medical devices, and food. These disruptions are caused by various...more

Bergeson & Campbell, P.C.

DOD Publishes 2025 Update on Critical PFAS Uses, Recommends Risk-Based Approach to Defining PFAS

The U.S. Department of Defense (DOD) has published a July 2025 report entitled Update on Critical Per- and Polyfluoroalkyl Substance Uses. House Report 118-121, which accompanied the 2024 DOD appropriations bill (H.R. 4365),...more

White & Case LLP

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

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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

Conn Maciel Carey LLP

Don’t Get Caught Off Guard: OSHA Renews Its Machine Safety (Amputations) National Emphasis Program

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OSHA announced that it is renewing its National Emphasis Program (NEP) to Address Amputations in Manufacturing. The renewed NEP will replace the previous version which expired on June 27 and will remain in place for five...more

Gardner Law

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

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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

Jackson Lewis P.C.

OSHA’s 2025 Amputations NEP: Key Changes Manufacturers Should Know

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The Occupational Safety and Health Administration (OSHA) has issued its 2025 update to the National Emphasis Program on Amputations in Manufacturing Industries (Amputations NEP), renewing the program and introducing several...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

Littler

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

Littler on

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

Bergeson & Campbell, P.C.

OECD Publishes Report on Commercial Availability and Current Uses of PFAS and Alternatives in Hydraulic Oils and Lubricants

On June 20, 2025, the Organisation for Economic Co-operation and Development (OECD) published a report entitled Per- and Polyfluoroalkyl Substances (PFAS) and Alternatives in Hydraulic Oils and Lubricants: Report on...more

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

MG+M The Law Firm

EPA Extends TSCA Section 8(d) Reporting Deadlines for Chemical Data Submissions

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The US Environmental Protection Agency (EPA) has announced plans to extend the reporting deadlines for a rule under Section 8(d) of the Toxic Substances Control Act (TSCA). This rule mandates that manufacturers and importers...more

King & Spalding

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

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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

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

Gardner Law

The Importance of a Clinical Trial Strategy

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Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....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

Bergeson & Campbell, P.C.

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

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

Shipman & Goodwin LLP

Federal Regulations Arriving ‘PFAShionably Late’ - A CBIA Manufacturing Spotlight Article

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A series of PFAS-related communications and rulemaking from the U.S. Environmental Protection Agency have recalibrated the agency’s focus areas and timeline under the second Trump administration. Federal PFAS regulation...more

Bergeson & Campbell, P.C.

TSCA Section 21 Petition Seeks Reconsideration of 2024 Rule Regarding Procedures for Chemical Risk Evaluation

On May 15, 2025, the Center for Environmental Accountability (CEA) filed a petition under Section 21 of the Toxic Substances Control Act (TSCA) requesting that the U.S. Environmental Protection Agency (EPA) reconsider the...more

Gardner Law

Staying Prepared Amid FDA Changes

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Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

Bergeson & Campbell, P.C.

EC Announces Low- and High-Risk Countries under the EUDR

The European Commission (EC) released on May 22, 2025, the identity of the countries that present a low or high risk of deforestation in producing seven commodities (cattle, cocoa, coffee, palm oil, rubber, soy, and wood)...more

Mitratech Holdings, Inc

EU Cyber Resilience Act: How to Prepare Now

The EU Cyber Resilience Act (CRA), adopted by the European Parliament in 2024, marks a major milestone in European cybersecurity legislation. As the first EU-wide law focused on the cybersecurity of digital products, it...more

Bergeson & Campbell, P.C.

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

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

J.S. Held

Beyond Safety & Effectiveness: Business Reasons to Prioritize Human Factors in Medical Device Design

J.S. Held on

To err is human. We have short attention spans and get distracted easily. We have unreliable memories and forget. We have a limited ability to process information, and we overgeneralize rules-of-thumb to the wrong situations....more

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