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📜FDA Guidance on Device Manufacturing Discontinuances and Notifications

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act." This guidance updates the previous version of the guidance, of the same title, issued on November 17, 2023, and finalizes the concurrently issued draft guidance entitled "Select Updates for the 506J Guidance: 506J Device List and Additional Notifications." This guidance finalizes a list of device product codes for which a manufacturer of such devices is required to notify FDA in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) (hereafter referred to as the "506J Device List") and clarifies that manufacturers may submit voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a public health emergency (PHE).

💊FDA Draft Guidance on Complying with 21 CFR 211.110 Available

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for Complying With 21 CFR 211.110." This guidance, when finalized, will describe considerations for complying with the requirements for ensuring batch uniformity and drug product integrity. In addition, this guidance discusses related quality considerations for drug products that are manufactured using advanced manufacturing. FDA is committed to supporting and enabling pharmaceutical innovation and modernization as part of the Agency's mission to protect and promote the public health. FDA encourages industry representatives and manufactures who are interested in using innovative control strategies to contact the Agency.

🏭GoPro's Proposed Production Activity in Foreign-Trade Zone 29

📊Antidumping Duty Order on Welded Pipe from Japan – Implications

The U.S. Department of Commerce (Commerce) finds that revocation of the antidumping duty (AD) order on welded large diameter line pipe (line pipe) from Japan would be likely to lead to continuation or recurrence of dumping at the levels indicated in the "Final Results of Sunset Review" section of this notice.

🚗New Seat Belt Warning System Regulations for Vehicle Manufacturers

This document amends Federal Motor Vehicle Safety Standard (FMVSS) No. 208, "Occupant crash protection," to require a seat belt use warning system for rear seats. The rule also updates and enhances the current seat belt warning requirements for the driver's seat belt and extends these requirements to the front outboard passenger seat. The final rule applies (with some exceptions) to passenger cars, trucks, most buses, and multipurpose passenger vehicles with a gross vehicle weight rating of 4,536 kilograms (10,000 pounds) or less. This document also makes related amendments to FMVSS No. 101, "Controls and displays."

⚠️EPA Final Risk Evaluation for Formaldehyde

The Environmental Protection Agency (EPA or Agency) is announcing the availability of the final risk evaluation under the Toxic Substances Control Act (TSCA) for formaldehyde. The purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or non-risk factors, including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, under the conditions of use. The Agency used the best available science to prepare this final risk evaluation and has determined, based on the weight of scientific evidence, that formaldehyde presents an unreasonable risk of injury to human health. Under TSCA, EPA must initiate risk management actions to address the unreasonable risk.