Short Takes – 7-1-25 – Federal Register Edition

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability. Federal Register FDA notice of availability. Summary: “The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” This guidance updates the previous version of the guidance, of the same title, issued on September 27, 2023, and finalizes the draft guidance entitled “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act” issued on March 13, 2024. This guidance provides FDA's recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. Additionally, this guidance has been updated to identify the information FDA generally considers to be necessary for cyber devices to support obligations under the new amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) for ensuring cybersecurity of devices.”

Determinations Regarding Use of Chemical Weapons by Sudan Under the Chemical and Biological Weapons Control and Warfare Elimination Act of 1991. Federal Register State Department public notice. Summary: “The Senior Official performing the functions of the Under Secretary for Arms Control and International Security, acting under authority delegated pursuant to an Executive order, has determined pursuant to section 306(a) of the Chemical and Biological Weapons Control and Warfare Elimination Act of 1991 (the Act), 22 U.S.C. 5604(a), that the Government of Sudan has used chemical weapons in violation of international law. In addition, the Senior Official performing the functions of the Under Secretary for Arms Control and International Security has determined and certified to Congress pursuant to section 307(d) of the Act (22 U.S.C. 5605(d)) that it is essential to the national security interests of the United States to partially waive the application of the sanctions required under section 307(a) of the Act with respect to foreign assistance, licenses and other authorizations for the export of items on the U.S. Munitions List (USML), and the licensing of national security-sensitive goods and technology. The following is a notice of the sanctions to be imposed pursuant to section 307(a) of the Act, subject to these waivers.”

Removal of Environmental Impact Analysis Process (EIAP) Regulation. Federal Register Air Force interim final rule. Summary: “The DAF is rescinding its National Environmental Policy Act (NEPA) regulations because the Council on Environmental Quality's (CEQ) NEPA regulations, which they were meant to supplement, have been rescinded, and because the DoD is promulgating Department-wide NEPA procedures that will guide DAF's NEPA process.” Comments due: July 31^st, 2025.

Amending the Medical Evaluation Requirements in the Respiratory Protection Standard for Certain Types of Respirators. Federal Register OSHA notice of proposed rulemaking. Summary: “OSHA is proposing to remove some medical evaluation requirements in the Respiratory Protection Rule for certain types of respirators. This proposed change would only impact filtering facepiece respirators and loose-fitting powered air-purifying respirators.” Comments due: September 2^nd, 2025.

Pipeline Safety: Integration of Innovative Remote Sensing Technologies for Right-of-Way Patrols on Gas and Hazardous Liquid Pipelines. Federal Register PHMSA direct final rule. Summary: “This DFR clarifies that PHMSA's right-of-way patrol requirements are technology neutral, and that remote sensing technologies, such as unmanned aerial systems and satellites, can be used for compliance purposes.” Comments due: September 2^nd, 2025.

Hazardous Materials: Improving Efficiencies for Special Permits and Approvals Renewals. Federal Register PHMSA notice of proposed rulemaking. Summary: “This NPRM streamlines the Hazardous Materials Regulations by allowing a grantee to file an application to renew a special permit or approval any time before its expiration date rather than requiring the application to be filed 60 days in advance.” Comments due: September 2^nd, 2025.