🏥FDA Announces Regulatory Review Period for Chocolate Touch Device
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CHOCOLATE TOUCH (PACLITAXEL DRUG COATED PTA BALLOON CATHETER) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Learn More🔒FDA Cybersecurity Guidance for Medical Devices
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updates the previous version of the guidance, of the same title, issued on September 27, 2023, and finalizes the draft guidance entitled "Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act" issued on March 13, 2024.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.
Learn More🏥Stakeholder Meetings for Medical Device User Fee Amendments
The Food and Drug Administration (FDA or the Agency) is issuing this notice to request that public stakeholders--including patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts--notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Medical Device User Fee Amendments (MDUFA). The statutory authority for MDUFA expires September 30, 2027. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next MDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.
Learn More🧬FDA Classification of Muscular Dystrophy Newborn Screening Test
The Food and Drug Administration (FDA, the Agency, or we) is classifying the muscular dystrophy newborn screening test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the muscular dystrophy newborn screening test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More🏥Unique Device Identifier Requirements for Combination Products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled "Unique Device Identifier (UDI) Requirements for Combination Products." This draft guidance is intended to assist industry and FDA staff in understanding how FDA's unique device identifier (UDI) requirements apply to combination products with device constituent parts.
Learn More⚕️FDA Modifications to Recognized Standards on Medical Devices
The Food and Drug Administration (FDA or the 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: 064" (Recognition List Number: 064), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Learn More🧬FDA Classifies Newborn Screening Test System Under Class II
The Food and Drug Administration (FDA, the Agency, or we) is classifying the lysosomal storage disorder newborn screening test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the lysosomal storage disorder newborn screening test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More🧬FDA Classifies Fluorescence Devices for Hematologic Malignancies
The Food and Drug Administration (FDA, the Agency, or we) is classifying the fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More💉FDA Classifies X-Ray Attenuation Cream Under Class II Devices
The Food and Drug Administration (FDA, the Agency, or we) is classifying the cream for x-ray attenuation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the cream for x-ray attenuation's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More🏥FDA Revokes EUA for Cepheid COVID-19 Diagnostic Device
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Cepheid for the Xpert Xpress SARS-CoV-2 test. FDA revoked the Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocation, which includes an explanation of the reason for revocation, is reprinted at the end of this document.
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