🧫FDA Reclassifies Hepatitis B Assays, Easing Market Entry
The Food and Drug Administration (FDA) is issuing a final order reclassifying qualitative hepatitis B virus (HBV) antigen assays (product code LOM), HBV antibody assays (product code LOM), and quantitative HBV nucleic acid-based assays (product code MKT), all of which are postamendments class III devices, into class II (special controls), subject to premarket notification. FDA is also establishing the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of these device types.
Learn More🧪CDC Requests Comments on Drug Susceptibility Testing Program
The CDC has submitted an information collection request for the Model Performance Evaluation Program related to Mycobacterium tuberculosis drug susceptibility testing. This initiative aims to enhance the quality of testing practices among U.S. laboratories. The program is designed to provide evaluations that help optimize laboratory capabilities in identifying drug-resistant tuberculosis strains, thereby informing continuous program improvement.
Learn More⚖️USMCA Correcting Amendments
On January 17, 2025, U.S. Customs and Border Protection (CBP) published an interim final rule in the Federal Register amending the CBP regulations to add implementing regulations for the preferential tariff treatment and related customs provisions of the Agreement Between the United States of America, the United Mexican States, and Canada (USMCA) related to general definitions, drawback and duty- deferral programs, textile and apparel goods, and automotive goods, among others. Errant amendatory instructions resulted in the inadvertent omission of two conforming amendments and the removal of two paragraphs that were unrelated to the USMCA amendments. This action corrects those errors.
Learn More🧪CDC Proposes Data Collection for Opioid Material Distribution
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Distribution of Traceable Opioid Material[supreg] Kits (TOM[supreg] Kits) across U.S. and International Laboratories. The purpose of this information collection request (ICR) is for the CDC to assure that the Traceable Opioid Material[supreg] Kits (TOM[supreg] Kits) are equitably distributed to domestic and international partner laboratories, and to allow CDC to understand the types of laboratories requesting these materials and the analyses that are being conducted.
Learn More⚖️New Drug Testing Regulations for Transportation Workers
The U.S. Department of Transportation (Department or DOT) proposes to amend its drug-testing program regulation, 49 CFR part 40 (part 40), to add fentanyl (a synthetic opioid) and norfentanyl (a metabolite of fentanyl) to its drug testing panels. The proposed rulemaking would harmonize part 40 with the U.S. Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), which DOT must follow for the minimum list of drugs for which DOT requires testing, and the comprehensive standards for laboratory drug testing per the Omnibus Employee Testing Act of 1991. Adding fentanyl and norfentanyl is also in the interest of transportation safety, given compelling information regarding the number of overdose deaths in the United States involving fentanyl. The Department also proposes to amend certain provisions of part 40 to harmonize, as appropriate, with the current HHS Mandatory Guidelines using urine (UrMG) and oral fluid (OFMG). This NPRM also proposes to clarify certain existing part 40 drug testing program provisions and to make technical amendments.
Learn More🦠FDA Classifies Multiplex Respiratory Panel for Respiratory Pathogens
The Food and Drug Administration (FDA, the Agency, or we) is classifying the multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens 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 multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens. 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 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 Device for Detecting Vaginitis-Related Microorganisms
The Food and Drug Administration (FDA, the Agency, or we) is classifying the device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis 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 device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis's classification. 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 Postnatal Chromosomal Detection System as Class II
The Food and Drug Administration (FDA, the Agency, or we) is classifying the postnatal chromosomal copy number variation detection 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 postnatal chromosomal copy number variation detection system's classification. 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 Mutation Detection Test for Myeloproliferative Neoplasms
The Food and Drug Administration (FDA, the Agency, or we) is classifying the mutation detection test for myeloproliferative neoplasms 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 mutation detection test for myeloproliferative neoplasms. 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.
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