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Hogan Lovells

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

Hogan Lovells on

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...

Ropes & Gray LLP on

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

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

Wiley Rein LLP

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

Wiley Rein LLP on

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

Hogan Lovells

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

Hogan Lovells on

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 Provides Technical Support for Companies Submitting New Chemical Data

Bergeson & Campbell, P.C. on

On April 25, 2025, the U.S. Environmental Protection Agency (EPA) announced the availability of new resources intended to help companies with the requirements described in EPA’s December 2024 final rule governing the review...more

Troutman Pepper Locke

FDA’s New Lead Guidelines: A Milestone for Safer Baby Foods

Troutman Pepper Locke on

In recent years, the safety of baby food has become a top priority for state attorneys general (AG) and federal agencies. In April 2021, the U.S. Food and Drug Administration (FDA) announced its “Closer to Zero” plan to...more

King & Spalding

OMB Finalizes Regulatory Guidance On “Buy America Preferences For Infrastructure Projects”

King & Spalding on

Revised guidance takes effect on October 22, 2023 and will be supplemented by forthcoming memorandum - On August 23, the Office of Management and Budget (“OMB”) published final Guidance for Grants and Agreements to...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Diisocyanate Storage Tank Systems: American Chemistry Council Guidelines (March 2018)

Mitchell, Williams, Selig, Gates & Woodyard,... on

The American Chemistry Council (“ACC”) issued a March 2018 document titled: Guidelines for Diisocyanate Storage Tank Systems (“Guidelines”) ...more

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