🔒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updates the previous version of the guidance, of the same title, issued on September 27, 2023, and finalizes the draft guidance entitled "Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act" issued on March 13, 2024.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📊Secretarial Comments on CBE's 2024 Activities Report Overview
This notice acknowledges the Secretary of the Department of Health and Human Services' (the Secretary's) receipt and review of Battelle Memorial Institute's, the consensus-based entity (CBE) under a contract with the Secretary, 2024 Annual Activities Report to Congress, as mandated by section 1890(b)(5) of the Social Security Act (the Act). The Secretary has reviewed CBE's 2024 Annual Report and is publishing the report in the Federal Register together with the Secretary's comments on the report not later than 6 months after receiving the report in accordance with section 1890(b)(5)(B) of the Act. This notice fulfills the statutory requirements. Although the Act requires the Secretary to review and publish the report, this statutory obligation does not constitute endorsement by the Secretary of the CBE's annual report and its specific recommendations.
Learn More🌍Notice of Care Delivery Area Redesignation for Iowa Tribe
Notice is hereby given that the Indian Health Service (IHS) has decided to expand the geographic boundaries of the Purchased/ Referred Care Delivery Area (PRCDA) for the Iowa Tribe of Kansas and Nebraska (Iowa Tribe or Tribe) to include the counties of Jackson in the State of Kansas, and Holt in the State of Missouri. The final PRCDA for the Iowa Tribe now includes the following counties: Brown, Doniphan, and Jackson in the State of Kansas; Holt in the State of Missouri; and Richardson in the State of Nebraska. The sole purpose of this expansion is to authorize additional Iowa Tribal members and beneficiaries to receive Purchased/Referred Care (PRC) services.
Learn More🏥PRCDA Redesignation Notice for Chippewa Cree Tribe in Montana
Notice is hereby given that the Indian Health Service (IHS) has decided to expand the geographic boundaries of the Purchased/Referred Care Delivery Area (PRCDA) for the Chippewa Cree Tribe of the Rocky Boy's Reservation ("Chippewa Cree Tribe" or "Tribe") to include the Montana County of Cascade. The final PRCDA for the Chippewa Cree Tribe now includes the Montana counties of Cascade, Choteau, Hill and Liberty. The sole purpose of this expansion is to authorize additional Chippewa Cree Tribal members and beneficiaries to receive Purchased/Referred Care (PRC) services.
Learn More📋Agency Information Collection Notice Impacting Medicare Regulations
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Learn More💊FDA Guidance on Antibacterial Therapies for Unmet Medical Needs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers." This guidance assists in the clinical development of new antibacterial drugs to treat serious bacterial diseases in patients with unmet medical needs, including patients with a serious bacterial disease for which effective antibacterial drugs are limited or lacking. This guidance finalizes the draft guidance entitled "Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers (Revision 1)" issued on May 24, 2022.
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📄CMS Proposed Information Collection and Comment Request Overview
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
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🏥PRCDA Expansion for Shoshone-Bannock Tribes in Idaho
Notice is hereby given that the Indian Health Service (IHS) has decided to expand the geographic boundaries of the Purchased/ Referred Care Delivery Area (PRCDA) for the Shoshone-Bannock Tribes of the Fort Hall Indian Reservation in Idaho (Shoshone-Bannock Tribes or Tribe) to include the Idaho counties of Ada, Bear Lake, Blaine, Bonneville, Butte, Canyon, Cassia, Custer, Elmore, Franklin, Fremont, Gem, Gooding, Jefferson, Jerome, Madison, Minidoka, Oneida, Payette, Teton, Twin Falls, and Washington. The final PRCDA for the Shoshone- Bannock Tribes now includes the Idaho counties of Ada, Bannock, Bear Lake, Bingham, Blaine, Bonneville, Butte, Canyon, Caribou, Cassia, Custer, Elmore, Franklin, Fremont, Gem, Gooding, Jefferson, Jerome, Lemhi, Madison, Minidoka, Oneida, Payette, Power, Teton, Twin Falls, and Washington. The sole purpose of this expansion is to authorize additional Shoshone-Bannock Tribal members and beneficiaries to receive Purchased/Referred Care (PRC) services.
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