Regulatory Compliance, Industry Guidance 7 Jan 2025 compliance, medical devices, fda guidance, labeling, performance testing, pulse oximeters

🩺FDA Draft Guidance on Pulse Oximeters for Regulatory Compliance

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Pulse Oximeters for Medical Purposes--Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations." This draft guidance document, when finalized, will provide recommendations regarding non-clinical and clinical performance testing of certain pulse oximeters for medical purposes,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 Among other topics, the draft guidance also proposes recommendations for labeling, which are intended to promote the safe and effective use of pulse oximeters and help users understand the benefits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 This draft guidance is not final nor is it for implementation at this time.

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Regulatory Requirements, Business Strategy 7 Jan 2025 postal service, public comments, business agreements, competitive products, regulatory commission

📦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.

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Grant Opportunities, Compliance 7 Jan 2025 grants, funding, nih, health, research, meeting, infectious diseases
Compliance, Regulatory Requirements 7 Jan 2025 compliance, regulations, fda, supply chain, manufacturing, medical devices

📜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).

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Advisory Councils, Regulatory Compliance, Environmental Sector 7 Jan 2025 business compliance, environmental management, noaa, marine sanctuaries, advisory council, chumash heritage

🌊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.

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Compliance, Regulatory Changes 7 Jan 2025 compliance, financial regulation, registration, sarbanes-oxley, pcaob
Regulatory Compliance, Marine Safety 7 Jan 2025 regulatory compliance, reporting and recordkeeping requirements, security measures, harbors, coast guard, waterways, marine operations, marine safety, navigation (water), safety zone, atchafalaya river

⚓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.

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Regulatory Compliance, Shipping Services 7 Jan 2025 regulatory compliance, business operations, postal service, negotiated service agreements, shipping

📦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.

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Regulatory Change, Business Strategy 7 Jan 2025 regulatory compliance, postal service, shipping, usps, business contracts

📦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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Compliance, Regulatory 7 Jan 2025 regulatory compliance, federal reserve, financial services, bank control, business acquisitions