❌FDA Terminates Arthritis Advisory Committee – Regulatory Update
The Food and Drug Administration (FDA or the Agency) is announcing the termination of the Arthritis Advisory Committee (Committee). Due to that termination, this final rule removes the Committee from the Agency's list of standing advisory committees in 21 CFR 14.100.
Learn More🏥FDA Classifies Liver Iron Concentration Imaging Diagnostic
The Food and Drug Administration (FDA, the Agency, or we) is classifying the liver iron concentration imaging companion diagnostic for deferasirox 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 classification of the liver iron concentration imaging companion diagnostic for deferasirox. We are taking this action because we have determined that classifying the device into class II 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⚛️Amendment to Certificate of Compliance 1042 for Spent Fuel Storage
The U.S. Nuclear Regulatory Commission (NRC) is amending its spent fuel storage regulations by revising the TN Americas LLC, NUHOMS[supreg] EOS Dry Spent Fuel Storage System listing within the "List of approved spent fuel storage casks" to include Amendment No. 4 to Certificate of Compliance No. 1042. Amendment No. 4 changes the certificate of compliance to incorporate a method to determine new loading patterns, introduce a steel plate composite option, introduce the use of MAVRIC software for a confirmatory run of the HSM-MX dose rates, make technical specification changes for consistency and terminology clarification, make various updated final safety analysis report editorial corrections for consistency and clarification, add measured exposures from past loading campaigns, allow use of a blended Portland cement, change the use of the MX-Loading Crane, and clarify the scenarios under which the maximum heat loads can be reduced.
Learn More⛏️MSHA Proposes Revision of Diesel Particulate Matter Regulations
MSHA is proposing to revise 30 CFR part 57 by removing outdated requirements for miners' exposures to diesel particulate matter (DPM) in underground metal and nonmetal mines (MNM). These revisions would streamline the requirements for DPM for underground MNM mine operators while maintaining the same level of protection for miners.
Learn More⚒️MSHA Proposes Removal of Outdated Trolley Safety Regulations
MSHA is proposing to remove and revise provisions for metal and nonmental (MNM) mines and coal mines regarding the use of trolleys for transportation of mined ore, coal, material, and personnel. Trolleys are an outdated technology that have been replaced by more efficient belt conveyor haulage systems for transporting mined ore and coal. Diesel and battery-operated mobile equipment are now used to transport personnel and equipment. Trolleys are no longer used in MNM or coal mines and there is no anticipated future use of this legacy equipment in MNM and coal mines.
Learn More⚒️Proposed Deregulation for Blacksmith Shops in Mining Operations
MSHA is proposing to revise 30 CFR part 57 to remove outdated requirements regarding blacksmith shops located at surface metal and nonmetal mines. Removal of this standard would not result in a reduction of safety protection for miners at surface metal and nonmetal mines.
Learn More🛠️New Rule Facilitates Non-Permissible PAPR Usage in Mining
MSHA is proposing to allow the use of non-permissible Powered Air Purifying Respirators (PAPRs) in specified underground areas of mines, if the equipment meets certain technical specifications and is operated under specific conditions. This proposed rule would codify technical specifications and working conditions to allow the use of non-permissible PAPRs in underground gassy mines. This proposed rule would reduce burden because mine operators would no longer need to submit a petition for modification to use non-permissible PAPRs.
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 Final Order on Radiological Computer-Assisted Detection Devices
The Food and Drug Administration (FDA, the Agency, or we) is classifying the radiological computer-assisted detection and diagnosis software 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 radiological computer-assisted detection and diagnosis software'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 Radiological Devices to Enhance Market Access
The Food and Drug Administration (FDA, the Agency, or we) is classifying the radiological acquisition and/or optimization guidance 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 radiological acquisition and/or optimization guidance 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.
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