🧪FDA Classifies Zika Virus Serological Reagents to Class II
The Food and Drug Administration (FDA, Agency, or we) is classifying the Zika virus serological reagents 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 Zika virus serological reagents' 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 Emergency Use Authorizations for COVID-19 Tests
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Pfizer Inc. for the Lucira COVID-19 All-In- One Test Kit and Lucira CHECK-IT COVID-19 Test Kit, MAWD Laboratories for the MAWD Laboratories SARS-CoV-2 Dual Target by RT-PCR, and Nuclein, LLC (merged with Molecular Diagnostics Inc.) for the DASH SARS-CoV-2/S Test. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
Learn More🩺FDA Classifies Non-Microbial Analytes Detection Device
The Food and Drug Administration (FDA, the Agency, or we) is classifying the device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections 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 to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections' 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⚙️Voriconazole Test System Classification
The Food and Drug Administration (FDA, Agency, or we) is classifying the voriconazole 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 voriconazole 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🏥NIH Notice
The National Institutes of Health announces a closed meeting for the National Institute of Allergy and Infectious Diseases to evaluate contract proposals for developing diagnostics for Mycoplasma genitalium infection. The meeting focuses on contract discussions that may include sensitive trade secrets and personal information, reflecting the importance of confidentiality in health-related innovations.
Learn More🧬NIH Notice
The National Institutes of Health (NIH) announces a closed meeting of the National Institute of Allergy and Infectious Diseases' Special Emphasis Panel to review contract proposals for the SBIR Phase II Program. The agenda includes evaluating innovative research related to CRISPR-based in vitro diagnostics, highlighting significant discussions on healthcare advancements and potential funding for small businesses.
Learn More🚑FDA Revokes Emergency Use Authorizations for COVID-19 Diagnostic Tests
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Beckman Coulter, Inc., for the Access SARS- CoV-2 IgG, Access SARS-CoV-2 IgM, and Access SARS-CoV-2 IgG II tests. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
Learn More🏥NIH Notice of Closed Meeting on Rapid Diagnostic Proposals
The National Institute of Allergy and Infectious Diseases has announced a closed meeting to review contract proposals for developing rapid diagnostic assays for self-monitoring HIV-1 infections. The meeting will evaluate confidential materials, highlighting the importance of compliance with trade secret protections. Affected stakeholders include those in the healthcare technology field.
Learn More🩺CDC's Road Map for Accelerated HCV Diagnosis
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. The goal of the convening will be for each person to give their individual input, and not to build consensus. No discussions, recommendations, or advice to CDC will occur or be provided at the meeting. Day 1 will focus on the utility of point-of- care (POC) testing for accelerating same-day HCV diagnosis and rapid treatment i.nitiation. Day 2 will focus on the utility of viral-first testing strategies for accelerating HCV diagnosis and treatment initiation in the United States. Following the meeting, APHL will prepare a meeting report summarizing the discussion and public comment received through regulations.gov, developed and documented as individual input to ensure thorough and complete input from partners. CDC and APHL will disseminate the APHL-prepared report as a reference for partners and industry to follow in developing and implementing future hepatitis C testing strategies. The final report will be added to docket CDC-2025-0002 once it is available.
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