BDRA Consulting LLC has been a member of AMDM since 2013. Come join AMDM for the entire story. Twice a year, members get to meet with the FDA to discuss upcoming regulatory and quality policies. The FDA provides industry updates. This year's meeting was held at Building 66, White Oak campus on May 21, 2024. Key Takeaways from the May 2024 AMDM Industry FDA Roundtable: 1. Cybersecurity for medical devices is a key issue. OHT7 and CDRH have increased focus on cybersecurity for medical devices. 2. The Oncology Diagnostic Pilot Program is nearly a year old, and no company has been accepted. This is primarily because drug manufacturers have not been able to provide validation data. 3. Reclassification plans for companion diagnostics are ongoing and will be completed by November 2027. - FDA is considering down-classifying three types of CDxʼs: i. Nucleic acid-based CDX ii. In situ hybridization-based CDX iii. Immuno-histochemistry-based CDX - Technologies will be grouped based on the intended use. 4. PCCP guidance for medical devices will be published before the end of the fiscal year 2024. A PCCP may be used to make changes to sample type changes, which may be acceptable in certain cases. 5. QSIT is being replaced by an entirely novel risk-based approach, which is currently being worked out. Manufacturers should be working through transition plans. #AMDM
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Why is the IVDR timeline so long? Under the European Union In Vitro Diagnostics Directive 98/79/EC (IVD-D), approximately 8% of IVDs required Notified Body involvement. Under European Union In Vitro Diagnostics Regulation 2017/746 (EU IVDR), approximately 80% of IVDs require Notified Body involvement. Given that there are 34,000 companies within the European medical device sector, and only 36 designated notified bodies for IVDR, the limited capacity of the notified bodies plus a slower than expected uptake and recognition of the regulation has contributed to the protracted timelines of the transition to this point. If you have any questions about IVDR, please contact dpyd@yourgenehealth.com to speak to an expert #DPYD #IVDR #DPYDGenotyping #PrecisionMedicine #Pharmacogenomics
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There are numerous challenges involved with bringing In Vitro Diagnostics (IVD) to market, including the fact that they are complex solutions, have less clinical investment and lack clear funding processes and guidelines. The ever-evolving landscape of healthcare regulations can also bring about unique challenges. Luckily, you don’t need to navigate the intricate process of bringing your IVD to market yourself – LFH Regulatory is here to help. Our highly skilled consultants ensure your IVDs meet and successfully adhere to regulatory standards. Explore how our comprehensive IVD regulatory services can help you now: https://lnkd.in/eFuZeG5t #Invitro #MedicalDevice #InvitroDiagnostics #IVD
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Managing Director @ LFH Regulatory Limited | Regulatory Affairs I Quality Assurance I Clinical Affairs I UKCA & CE Marking I FDA I QMS I ISO 13485 I Global Registrations
There are numerous challenges involved with bringing In Vitro Diagnostics (IVD) to market, including the fact that they are complex solutions, have less clinical investment and lack clear funding processes and guidelines. The ever-evolving landscape of healthcare regulations can also bring about unique challenges. Luckily, you don’t need to navigate the intricate process of bringing your IVD to market yourself – LFH Regulatory is here to help. My highly skilled consultants ensure your IVDs meet and successfully adhere to regulatory standards. Explore how our comprehensive IVD regulatory services can help you now: https://lnkd.in/eSrUNrws #Invitro #MedicalDevice #InvitroDiagnostics #IVD
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SeaStar Medical’s Selective Cytopheretic Device for cardiorenal syndrome receives US FDA Breakthrough Device Designation. SeaStar Medical Holding Corporation, a medical device company, announces receipt of US Food and Drug Administration (FDA) Breakthrough Device Designation for its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) for use with patients in the hospital intensive care unit (ICU) with acute or chronic systolic heart failure and worsening renal function due to cardiorenal syndrome or right ventricular dysfunction awaiting implantation of a left ventricular assist device (LVAD). The Breakthrough Device Designation is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population. This is only the ninth Breakthrough Device Designation granted by the FDA’s Center for Biologics Evaluation and Research (CBER) since the program’s inception in 2015. “Cardiorenal syndrome is seen in the most severe cases of heart failure and is associated with a very poor prognosis,” said Kevin Chung, MD, chief medical officer of SeaStar Medical. “The SCD is able to halt the downward spiral often perpetuated by a hyperinflammatory state driven by the innate immune system, giving these patients a fighting chance.” #marketing #motivation #education #business #networking #health #inspiration #innovation #management #technology #foodandbeverage #healthawareness #innovateresearch #pharmanews #todaysnews #drug #research #marketing #clinicatrials #cro #clinicalresearch Innovate Research
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https://lnkd.in/gpcgbK4E Key Insights: • The FARAPULSE PFA System offers a unique approach, utilizing tissue-selective, non-thermal electric fields for heart tissue ablation, avoiding damage to surrounding structures during the procedure Visit MedicoInsights to explore key insights #HealthcareNews #drugs #StayInformed #MedicalNews #drugapproval #HealthTrends #Insights #HealthIndustry #HealthInnovation #bostonscientific #devices #medicaldevices #HealthcareAnalytics #NewsUpdate #HealthcareNetworking #pharma #pharmaceuticals #pharmanews #pharmaindustry #pharmainnovation #update #medicoinsights
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IMDRF: In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC) This document has been developed for in-vitro diagnostics medical device (IVD) regulatory submissions with the aim of creating a comprehensive submission structure that minimizes regional divergences and indicates where regional variation exists. This document is intended to provide guidance regarding the location of submission elements in the internationally defined structure. #IMDRF #IVDs #Submissions
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https://lnkd.in/gpcgbK4E Key Insights: • The FARAPULSE PFA System offers a unique approach, utilizing tissue-selective, non-thermal electric fields for heart tissue ablation, avoiding damage to surrounding structures during the procedure Visit MedicoInsights to explore key insights #HealthcareNews #drugs #StayInformed #MedicalNews #drugapproval #HealthTrends #Insights #HealthIndustry #HealthInnovation #bostonscientific #devices #HealthcareAnalytics #NewsUpdate #HealthcareNetworking #pharma #pharmaceuticals #pharmanews #pharmaindustry #pharmainnovation #update #medicoinsights
Boston Scientific Receives FDA Approval for FARAPULSE™ Pulsed Field Ablation System
https://medicoinsights.com
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📢 Member views sought on the Therapeutic Goods Administration's companion diagnostic guidance update AusBiotech is seeking feedback on the TGA’s updated draft Companion Diagnostics (CDx) Guidance document to form an industry-led response. The proposed updates aim to provide sponsors and manufacturers of medicines, biologicals and in vitro diagnostics (IVD) medical devices further clarification regarding the requirements for companion testing, including...https://lnkd.in/gt3apa-e Read the guidance update here 👇 https://lnkd.in/gzFQpcDm #companiondiagnostics #TGA
Companion diagnostics guidance update- public consultation
consultations.tga.gov.au
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💡 IMDRF - Exciting Update in the In Vitro Diagnostic Device Regulation 💡 We are thrilled to announce the release of the new edition of the document: "IMDRF/RPS WG/N13 FINAL:2024 (Edition 4) In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)" dated 25 June 2024. 🔎 Key Highlights: 👉 Updated content reflecting the latest industry standards and regulatory requirements 👉 Improved structure for ease of use and navigation 👉 Enhanced guidance to facilitate consistent and efficient submissions. What This Means for You ❓ 🔸 Simplified Regulatory Submissions: The updated structure and clear guidelines help reduce the complexity of preparing and submitting regulatory documents, saving time and resources. 🔸 Enhanced Consistency: With standardized templates and requirements, you can ensure that your submissions meet the expectations of regulatory authorities across different regions, minimizing the risk of rejection or requests for additional information. 🔸 Improved Efficiency: The streamlined process allows for faster review times by regulatory bodies, facilitating quicker time-to-market for innovative IVD products. 🔸 Global Harmonization: Aligning with international standards helps in navigating multiple regulatory environments more seamlessly, supporting global market expansion. We encourage all stakeholders in the IVD sector to review this new edition and integrate its guidelines into their regulatory processes. ⭐ To keep up to date with the latest news, subscribe to the EXPEREG page or to our consultants Juliette Desvilles / Franck Martin / David HOUOT #IVD #MedicalDevices #RegulatoryAffairs #IMDRF #Innovation #Healthcare
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IMDRF News! (In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)) Today (25-June), the IMDRF has published final document on "In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)". This document creates a comprehensive submission structure that minimizes regional divergences and indicates where regional variation exists. This document is intended to provide guidance regarding the location of submission elements in the internationally defined structure. This Updated document provides significant revisions based on policy changes in regions since the last update which occurred in 2019. Alongside this the IMDRF has published an updated document for Non-In Vitro Diagnostic Devices. Link In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC): https://lnkd.in/eg9c2b8J Link Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC): https://lnkd.in/eG9WQBy3 For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us. #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #euivdr #hospital #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #ivd #IMDRF
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