🩺FDA Draft Guidance on Pulse Oximeters for Regulatory Compliance
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Pulse Oximeters for Medical Purposes--Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations." This draft guidance document, when finalized, will provide recommendations regarding non-clinical and clinical performance testing of certain pulse oximeters for medical purposes, including devices with a pulse oximeter function that estimates the amount of oxygen in arterial blood and pulse rate. These recommendations are being proposed based in part on concerns that the accuracy of pulse oximeters can be affected by, among other factors, a person's skin pigmentation. The recommendations are being proposed to inform the performance evaluation for these devices, to support premarket submissions, regardless of submission type, and to promote consistency and facilitate efficient review of these submissions. Among other topics, the draft guidance also proposes recommendations for labeling, which are intended to promote the safe and effective use of pulse oximeters and help users understand the benefits and risks associated with the use of the device. This draft guidance is not final nor is it for implementation at this time.
Learn More📦Postal Regulatory Commission Notice on New Service Agreements
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Learn More📜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previous version of the guidance, of the same title, issued on November 17, 2023, and finalizes the concurrently issued draft guidance entitled "Select Updates for the 506J Guidance: 506J Device List and Additional Notifications."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).
Learn More🌊NOAA Announces New Advisory Council for Chumash Heritage Sanctuary
Notice is hereby given that NOAA is establishing a national marine sanctuary advisory council for the Chumash Heritage National Marine Sanctuary (CHNMS), the designation of which became effective on November 30, 2024. The council will provide guidance to ONMS and will serve as liaisons with constituents and community groups. As a result, ONMS is adding the new council to the list of established national marine sanctuary advisory councils. ONMS solicits applications to fill council seats on an as needed basis and is seeking applicants for seats on the CHNMS Advisory Council. This notice contains web page links and contact information for CHNMS and application materials to apply for the newly established advisory council.
Learn More⚓Temporary Safety Zone Established for Cypress Passage Powerline Demolition
The Coast Guard is establishing a temporary safety zone for navigable waters within a 500-yard radius of 29[deg]47'38.18" N, 91[deg]21'50.52" W, approximately MM 105.5, on the Atchafalaya River, locally known as Cypress Passage, during an overhead electrical powerline structure demolition operation on Thursday, January 9, 2025. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by the demolition of the powerline structures resulting in electrical powerlines on the navigational water's surface. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Marine Safety Unit Houma.
Learn More📦Notice of Postal Service Product Change for Business Shipping Options
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Learn More📦USPS Notice of Product Change for Priority Mail and Ground Advantage
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
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