💡NIH Licensing Opportunities for Novel Tissue Oximeter Technology
The National Institute of Child Health and Human Development (NICHD), an institute of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is giving notice of the licensing or collaboration opportunities for the inventions listed below, which are owned by an agency of the U.S. Government and are available for licensing and collaboration to achieve expeditious commercialization of results of federally-funded research and development.
Learn More📋FDA Seeks Comments on Medical Device Reporting Regulations
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collections associated with requirements for medical device reporting for user facilities, manufacturers, importers, and distributors of medical devices.
Learn More🧪FDA Notice on Reagents for Detection of Specific Novel Influenza A Viruses
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with Agency guidance on reagents for detection of specific novel influenza A viruses.
Learn More📄FDA Notice on Financial Disclosure for Clinical Investigators
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Learn More⚖️Notice of Complaint Received by U.S. International Trade Commission
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Balloon Dilation Devices, Systems, and Components Thereof, DN 3822; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.
Learn More🩺CMS Medicare Evidence Development Advisory Meeting Notice
This notice announces a virtual public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) ("Committee") will be held on Wednesday, June 25, 2025.
Learn More⚙️FDA Modifies Recognized Standards for Medical Devices
The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 063" (Recognition List Number: 063), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Learn More🚑FDA Revokes Emergency Use Authorizations for COVID-19 Diagnostic Tests
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Beckman Coulter, Inc., for the Access SARS- CoV-2 IgG, Access SARS-CoV-2 IgM, and Access SARS-CoV-2 IgG II tests. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
Learn More🥩FDA Regulation on Myoglobin as Color Additive for Meat Alternatives
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products. We are taking this action in response to a color additive petition (CAP) submitted by Motif FoodWorks, Inc. (Motif FoodWorks or petitioner).
Learn More🩺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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