🧬FDA Classifies Cancer Predisposition Risk Assessment Systems
The Food and Drug Administration (FDA, the Agency, or we) is classifying the cancer predisposition risk assessment 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 classification of the cancer predisposition risk assessment system. 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🩺FDA Classifies Orthopedic Surgical Instruments as Class II Devices
The Food and Drug Administration (FDA, the Agency, or we) is classifying orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices 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 orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices. 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🦴FDA Classifies Orthopedic Surgical Instruments as Class II Devices
The Food and Drug Administration (FDA, the Agency, or we) is classifying orthopedic manual surgical instrumentation for use with total disc replacement devices 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 orthopedic manual surgical instrumentation for use with total disc replacement devices. 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📋CMS Public Comment Notice on Information Collection Activities
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🏥Public Comment Request on Organ Procurement Membership Forms
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Learn More⚖️DEA Revokes Registration of Texas Doctor for Non-Compliance
The Drug Enforcement Administration has revoked the medical license of Dr. Andrew Konen, citing non-compliance with regulations concerning the prescription of controlled substances. The decision follows findings of numerous violations related to the issuance of prescriptions lacking legitimate medical purpose and inadequate patient evaluations, underscoring the critical importance of strict adherence to regulatory standards in medical practice.
Learn More🏥OSHA Extends Comment Period on COVID-19 Exposure in Healthcare
OSHA is extending the period for submitting comments by 60 days to allow stakeholders interested in the Notice of Proposed Rulemaking (NPRM) on Occupational Exposure to COVID-19 in Healthcare Settings additional time to review the NPRM and collect information and data necessary for comment.
Learn More🦠CDC Sets Roadmap for Accelerated HCV Diagnosis and Treatment
The Centers for Disease Control and Prevention (CDC) announces a two-day convening hosted and facilitated by the Association of Public Health Laboratories (APHL) to discuss hepatitis C diagnostics. Leaders from public health, laboratory, medical, academic, and industry sectors will have the opportunity to provide individual input, without building a consensus, on accelerating the diagnosis of current hepatitis C virus (HCV) infection. Members of the public with interest and expertise in diagnosing HCV infection are also invited to provide individual input. Specifically, the convening will focus on how to leverage the following hepatitis C diagnostic methods: same-day diagnosis and treatment, and viral-first testing.
Learn More🚫DEA Revokes Registration for Physician Following License Suspension
The Drug Enforcement Administration has issued an Order to Show Cause for the revocation of Kenneth Pherson, D.O.'s registration, citing the suspension of his state medical license in Florida. This decision emphasizes the necessity for practitioners to maintain state authority to prescribe controlled substances, as federal compliance hinges on state licensure. The document details the procedural actions taken by the DEA and the implications of default by the registrant.
Learn More🏥Notice of Meeting - National Institute of Environmental Health Sciences
The Department of Health and Human Services announces a public meeting by the National Institute of Environmental Health Sciences' Board of Scientific Counselors. Open sessions will cover various topics including Q&A sessions, while closed sessions will evaluate grant applications and personnel qualifications. The meeting is open to public attendance and also available via videocast.
Learn More