In the 4th installment of #BreakingDownTraceability, we define Critical Tracking Events (CTEs). Read a description of each CTE as defined by FDA and the Key Data Elements (KDEs) required for each CTE here: https://hubs.ly/Q02JWGVg0
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CLSI’s latest perspective on the FDA ruling regarding Laboratory Developed Tests (LDTs) underscores the growing need for laboratories to adapt to regulatory changes proactively. The report not only highlights the collective concerns of the lab community but also emphasizes the importance of leveraging available resources, such as the CLSI’s comprehensive LDT Toolkit. This toolkit can empower labs to navigate regulatory shifts with greater control and preparedness, ensuring they remain compliant while continuing to innovate in test development. It's a timely reminder of the critical role that robust guidance plays in safeguarding the quality and reliability of laboratory testing in an evolving landscape.
CLSI is excited to share a new perspective piece, entitled “The FDA Ruling on Laboratory Developed Tests: Taking Control of What’s in Your Control.” This new report shares summary results from a May 2024 member survey and aggregates helpful CLSI guidance and materials that can serve as an “LDT Toolkit” for the laboratory community. Access it here >> https://ow.ly/Qxfw50SWm7W.
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Dedicated Academician Turned Medical Writer || 10+ years of experience || Passionate about drafting Medical / Scientific documentation || Seeking New Challenges
An FDA guidance document summary has a typo. We All Make Mistakes: It's How We Learn and Grow That Matters Source: https://lnkd.in/gidnJde5
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Getting an FDA Information Request (IR) can feel like a roadblock. But fear not! Our comprehensive guide equips you to: ✅ Understand IRs & craft clear, concise responses ✅ Avoid delays & ensure your response meets FDA requirements ✅ Effectively communicate with the agency throughout the process Don't let IRs slow you down! Download the guide today and be prepared to confidently address any FDA requests. ➡️ https://hubs.la/Q02ykYk70 #FDA #ClinicalTrials #DrugDevelopmenrt #RegulatoryAffairs
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Looking to navigate FDA warning letters with confidence? Check out John Daley's whitepaper for expert tips on the 4 main causes 📝 Gain in-depth knowledge and actionable strategies to achieve compliance with ease. https://lnkd.in/eWKNnsgv #FDACompliance #ExpertTips #RegulatoryCompliance 🌟
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Purpose-driven healthcare leader | Cell & Gene Therapy | Radiopharmaceutical | Biotech & Pharmaceutical | Regulatory Compliance and Transformation
💡 Check out this insightful whitepaper by my colleague, John Daley. Highly recommended for great insights!
Looking to navigate FDA warning letters with confidence? Check out John Daley's whitepaper for expert tips on the 4 main causes 📝 Gain in-depth knowledge and actionable strategies to achieve compliance with ease. https://lnkd.in/eWKNnsgv #FDACompliance #ExpertTips #RegulatoryCompliance 🌟
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FDA takes action aimed at helping to ensure the safety and effectiveness of laboratory developed tests. Read the article here: https://lnkd.in/gjcMbHYV. #FDA #LaboratoryDevelopedTests #LDTs #FoodAndDrugAdministration #Action #Safety #Effective
FDA takes action aimed at helping to ensure the safety and effectiveness of laboratory developed tests
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Biomedical Engineering Professional/Leader, with Expertise in SDLC and Experience in Bioinformatics, SaMD, SiMD, Digital Health, Precision Medicine, and Global Health (Quality Matters to Deliver Great Products)
The US FDA has updated its recognized consensus standards database (https://lnkd.in/gWtaiAt4). This time they added/updated 60 standards to the database across different domains and they seem to have a cadence to update this database biannually (though somehow they claim quarterly.). As technology and standards keep evolving, medical device/IVD manufacturers would be prudent to monitor this database and do a corresponding gap analysis to see whether the product/process requirements are still up-to-date with what the regulatory agency expects either in the US, EU, or other international markets and potentially speed up the submission process. On the other hand, from a requirement engineering perspective, many requirements could be triggered/sourced from standards even if they are voluntary in the majority of the cases. Some standards are abstracted below for a quick search: - AAMI TIR28:2016/(R)2020; Product Adoption And Process Equivalence For Ethylene Oxide Sterilization - ISO 17665:2024 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices - ISO 14644-9:2022 Cleanrooms and associated controlled environments Part 9: Assessment of surface cleanliness for particle concentration - IEEE 11073-10206-2022 IEEE Standard - Health informatics -- Device interoperability -- Part 10206: Personal health device communication -- Abstract Content Information Model - ISO/IEEE 11073-10404:2022 Health informatics — Device interoperability Part 10404: Personal health device communication — Device specialization — Pulse oximeter - ISO/IEEE 11073-10407:2022 Health informatics — Device interoperability Part 10407: Personal health device communication — Device specialization — Blood pressure monitor - ISO/IEEE 11073-10408:2022 Health informatics — Device interoperability Part 10408: Personal health device communication — Device specialization — Thermometer - ISO/IEEE 11073-20601:2022 Health informatics — Device interoperability Part 20601: Personal health device communication — Application profile — Optimized exchange protocol - IEEE 2010-2023 IEEE Recommended Practice for Electroencephalography (EEG) Neurofeedback Systems - IEEE 11073-10101b-2023 IEEE Standard for Health Informatics--Device Interoperability Part 10101: Foundational--Nomenclature Amendment 1: Additional definitions - CLSI MM24 Molecular Methods for Genotyping and Strain Typing of Infectious Organisms, 1st Edition - ISO 780:2015 Packaging — Distribution packaging — Graphical symbols for handling and storage of packages - ... #USFDA #Standards #IEC #ISO #CLIA #IEEE #BiomedicalEngineering #RequirementEngineering #Standardized #Interoperability #DigitalHealth #Sterilization #IVD #MedicalDevice #NeuralEngineering #Packaging #MDSW #SaMD #SiMD #CLSI #LDT
The FDA has updated its Recognized Consensus Standards database, known as “List 62.” The update includes new standards, including one in the ASCA program. List 62 also contains new versions of recognized standards, and revision to one standard’s extent of recognition. Find out more: https://lnkd.in/e5rjGGP
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🔬📢 Follow up from the FDA Webinar on Laboratory Developed Tests (LDTs)! The recent FDA webinar shed light on the agency's plan for a four-year phase-out period for Laboratory Developed Tests (LDTs), marking a significant shift in regulatory oversight. The full recording and transcript will be posted by the FDA. As we navigate this transition, it's essential for laboratories to stay informed and prepared for potential changes ahead. How will this phase-out impact your laboratory? Join the conversation and share your thoughts! Don't miss the next FDA webinar on LDTs scheduled for June 5, 2024, where the focus will be on "Draft Guidances on Immediate Response Tests and Consideration of Enforcement Policies for Tests in the Context of a 564 Declaration." Save the date and stay tuned for more insights! 🧪#FDALDTWebinar #HealthcareInnovation #RegulatoryUpdate
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Director of Clinical Research Operations @ the University of Pennsylvania- Abramson Cancer Center Clinical Research Unit
View all Official FDA Guidance Documents and other Regulatory Guidance: You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period: https://lnkd.in/eAfW-r53
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