Clinical and Laboratory Standards Institute (CLSI)’s Post

Important Update: Effective now, clinical laboratories performing antimicrobial susceptibility testing (AST) are required to use breakpoints currently recognized by CLSI or FDA. Together CLSI, APHL - Association of Public Health Laboratories, American Society for Microbiology, College of American Pathologists (CAP), and Centers for Disease Control and Prevention have jointly developed this Breakpoint Implementation Toolkit (BIT) to assist clinical laboratories in updating minimal inhibitory concentration (MIC) breakpoints. Click here to use it for free >> https://ow.ly/KTW350QkjA0.

Did you know? The FDA’s Center for Devices and Radiological Health (CDRH) has announced its intent to kickstart the reclassification process for most In Vitro Diagnostic Devices (IVDs) that currently fall under class III (high risk), aiming to transition them into class II (moderate risk). Under the proposed reclassification, a majority of these IVDs, particularly those concerning infectious diseases and companion diagnostics, may undergo a less burdensome premarket notification (510(k)) pathway instead of the more stringent premarket approval process. This shift could potentially streamline the regulatory process. Furthermore, CDRH emphasizes its commitment to a risk-based approach in the initial classification of IVDs, considering factors that warrant class II designation through De novo classification. Stay tuned for further updates as the reclassification process unfolds. Learn more about the initiative on the FDA's official website: https://lnkd.in/e5JmxmkJ #medicaldevices #innovation #FDA #ivds #medicaldeviceregulation

Exciting News in the Medical Device World! The FDA's Center for Devices and Radiological Health (CDRH) is embarking on a significant move. They intend to initiate the reclassification process for a majority of in vitro diagnostic (IVD) tests – think infectious diseases and companion diagnostics – currently deemed Class III (high risk). What are your thoughts on this? Share your insights below! This potential reclassification to Class II (moderate risk) could pave the way for a less rigorous premarket notification (510(k)) pathway, offering a streamlined approval process for these crucial tests. 🌐 Why does this matter? 🤔 Reclassification is like a regulatory game-changer! It means these tests might shift to Class II, providing an opportunity for a more efficient premarket notification (510(k)) pathway instead of the more stringent premarket approval route. In a nutshell, it's a strategic move to make the approval process smoother for certain IVDs. Stay tuned for updates on this exciting development! 🌟 #FDA #MedicalDevices #RegulatoryNews #HealthcareInnovation #invitrodiagnostics #diagnostictesting #510k #northeasternuniversity #northeastern #medicaldevices #medicaldeviceregulation

Did you know? The FDA's Center for Devices and Radiological Health (CDRH) is paving the way for significant changes in the classification of In Vitro Diagnostic Devices (IVDs). Read more about this news in the shared post. MDR Consultants Inc. #fda #fdacompliance #fdaregulations

See the FDA's post (below) regarding an announcement by #CDRH that the Center intends to down classify "most high risk IVDs". The FDA website (available at the link in the FDA's post, below) explains the majority of these tests are infectious disease and companion diagnostic (#CDx) #IVDs. The webpage includes a link to information from a September 2023 panel meeting and explains that the panel discussed and has already made recommendations regarding a potential future reclassification from class III to class II with special controls of three types of infectious disease diagnostic tests: *Nucleic acid & serology-based IVDs to aid in the diagnosis of Hepatitis B Virus (HBV) infection and/or for use to aid in the management of HBV infected patients. *Serology-based IVDs to aid in detection of human parvovirus B19. *Cell-mediated immune reactivity IVDs to aid in the identification of in vitro responses to peptide antigens that are associated with Mycobacterium TB infection &/or use as detection of effector T cells that respond to stimulation by M. tuberculosis agents. Reclassification will lower the burden related to premarket submissions, allowing for premarket notification (510(k) vs. premarket approval (PMA). #FDA #CDRH #IVD #CDx #classifcation #510k

More CDRH Info Today - the Center intends to reclassify certain IVD tests from Class III to Class II, which would open the door to a less burdensome pathway to market for these types of IVDs. #FDA #CDRH #lifesciences #LDTs #healthlaw

🗣️ “We need to determine how to preserve the effectiveness of current and future #antibiotics as long as possible – this is where in vitro diagnostics plays a key role.” – Dr. Chuck Cooper, Executive Vice President Medical Affairs, Chief Medical Officer, bioMérieux   We are committed to developing solutions to slow the spread of Antimicrobial Resistance for improved patient outcomes. Read more key quotes and highlights from our joint conference with the Ambassade de France aux Etats-Unis in DC on May 14: “Rising to the Challenge: United Against Antimicrobial Resistance”. ⤵️ #PioneeringDiagnostics

🧪 On October 3, 2024, the WHO approved the first mpox in vitro diagnostic through its Emergency Use Listing procedure. According to the organization's press release, this approval marks a move toward global access to mpox testing, a positive step forward in public health efforts to mitigate disease spread. The Alinity m MPXV assay is manufactured by Abbott Molecular Inc. and was authorized for emergency use by the FDA in October 2022, months after the HHS declared the mpox public health emergency. The test is a real-time polymerase chain reaction (PCR) test that can detect the clade I and clade II mpox virus. Viral samples are collected from human lesion swabs, and the PCR is run by trained clinical laboratory personnel. #GlobalHealth #InVitroTesting #Mpox #WHOUpdate #EmergencyResponse #PandemicPreparedness #HealthSecurity #PublicHealth #InfectiousDiseases #DiagnosticTests #LaboratoryTesting #DiseasePrevention

I am proud to announce that another clinical trial was published on our UTI products! >Your< UTI Free Sachets were clinically shown to dramatically improve antibiotic UTI treatment, resolving its key drawback of recurrent infections. The addition of >Your< UTI Free Sachets to antibiotic treatment resulted in: • over 4x times lower chance of relapse • a median recurrence rate of 0 • over 20% higher improvement in quality of life With our UTI products, we address the 2 key issues of UTIs – recurrence and antibiotic resistance. The study enables healthcare professionals to prescribe a proven solution confidently and empowers women to take control of their health. For brand owners, these products present a tested solution with a remarkable user experience and a high repurchase rate. They are already number 1 in 2 European markets, and the new clinical data only increases the opportunity. We will present the results and more details of the study in a webinar on February 29th. Register here: https://lnkd.in/dAtdJUhG

👉 Read our latest press release regarding the initiation of a DOOR MAT* study in the United States, https://lnkd.in/dw3Khuzs * Desirability of Outcome Ranking for the Management of Antimicrobial Therapy #bloodstreaminfections #rapidAST #AntibioticStewardship