Marwood Group’s Post

The LDT Final Rule was viewed by many in the in vitro diagnostics space as a costly burden. Navigating FDA premarket review, oversight, and quality compliance isn't easy. But using the LDT pathway to go fast and break things, as companies like Theranos once did, is not sustainable. Particularly as IVDs advance in their complexity, personalization, novelty, and influence on critical healthcare decisions. The good news is that there are genuine market incentives for pursuing an FDA submission. The FDA can play an important role in enabling differentiation, uptake, and product-specific coverage for IVDs with superior clinical evidence. This white paper includes case studies demonstrating these market access benefits for those IVD developers that decide to proactively pursue FDA approval.

Summary of IVDR Scope and Key Dates The European Union In Vitro Diagnostics Regulation 2017/746 (EU IVDR) expanded upon IVD Directive 98/79/EC (IVD-D) requirements, which have been in effect since 1998. The changes come into effect immediately, without having to be implemented into the respective states’ laws. Whilst some things, like the number of risk device classes, are remaining the same, the scope of the IVDR changes are wide reaching, with key changes as follows: Product scope expansion Reclassification of devices according to risk More stringent clinical evidence More stringent documentation Implementation of unique device identification Rigorous post-market surveillance Nomination of a responsible person for regulatory compliance Increased Notified Body involvement The intention of the regulation is to set tighter and broader requirements for the quality, performance and safety of IVD products, with implications for both manufacturers and consumers. Learn more about Yourgene's IVDR timeline on our website: https://hubs.la/Q0281mW10 Yourgene are committed to sharing our IVDR expertise with our distribution partners and end users – we will be bringing you informative content to help guide you through your IVDR fears. If you have any questions about IVDR, please contact dpyd@yourgenehealth.com to speak with an expert. #DPYD #IVDR #DPYDGenotyping #PrecisionMedicine #Pharmacogenomics #DPD

Is your in vitro diagnostic product labeled for Research Use Only (RUO) or for Investigational Use Only? Make sure the labeling matches such a use, or the FDA could find that the device is intended for clinical diagnostic use instead. 📧 FDA's newly issued warning letter contains some factors to consider when determining whether associated materials and practices might be contrary to a product's ROU categorization. https://lnkd.in/ghSvDMrm #IVD #RUO #meddevice #compliance #FDA #regulatory 

Great and informative article!

Upcoming Webinar | Save the date: July 11, 2024 We’re hosting a webinar on everything you need to know about IVD clinical trials. Join us to learn the latest best practices and insights. Signup for the webinar: https://bit.ly/4bY4T5n Learn more about Cloudbyz eClinical at info@cloudbyz.com #CTMS #eTMF #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #webinar

🔬 Navigating IVD product challenges with NAMSA 🔬 Embark on a journey of seamless IVD device approvals with NAMSA! 🚀 Our In Vitro Diagnostics team transforms complex regulatory and clinical challenges into streamlined strategies, ensuring top-tier product quality, compliance and clinical trials. Understanding the unique nature of IVD devices from specimen management to importing instrument data and clear technical file reports - trust NAMSA has the experts to support the unique needs of your IVD device across multiple diagnostic areas and user environments. Here's why you should choose NAMSA: ✨ Key Stats -Supported 200+ global IVD studies 🌍 -Managed 500+ IVD trial sites 🏥 -Submitted 170+ global regulatory submissions 📑 Why NAMSA for IVD? Our experts simplify the path to market approval for life-changing IVD products. From regulatory assessments to clinical trials and quality systems, we cover it all. Partner with the most flexible IVD CRO in the industry — your success is our commitment. Ready to elevate your IVD journey? Contact us now! https://lnkd.in/gMsv5hsd 🌐✉️ #IVD #RegulatoryCompliance #ClinicalTrials #NAMSAKnows

Upcoming Webinar | Save the date: July 11, 2024 We’re hosting a webinar on everything you need to know about IVD clinical trials. Join us to learn the latest best practices and insights. Signup for the webinar: https://bit.ly/4bRcuTn Learn more about Cloudbyz eClinical at info@cloudbyz.com #CTMS #eTMF #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #webinar

As we continue our series on the LDT Final Rule, it’s time to turn our attention to the IVD (In Vitro Diagnostics) manufacturers. The new regulations bring significant changes that could impact turnaround times for FDA reviews and pose compliance challenges. But don't worry – with proactive strategies, IVD manufacturers can navigate these changes effectively. In our latest post, we discuss the specific impacts on IVD manufacturers and provide practical advice for managing potential delays and ensuring compliance. 🔍 Key Highlights: Turnaround Time Concerns Understanding the Impact on Review Processes Strategies for Managing Delays Compliance Challenges Adapting to New Regulatory Requirements Implementing Effective Compliance Strategies 👉 Read the full article on our blog: https://lnkd.in/gurKSyUc Stay tuned for our next post where we will explore the impacts of the LDT Final Rule on RUO manufacturers and provide guidance on adapting to the new limitations and submission requirements. #IVDManufacturers #LDTFinalRule #FDACompliance

Upcoming Webinar | Save the date: July 11, 2024 We’re hosting a webinar on everything you need to know about IVD clinical trials. Join us to learn the latest best practices and insights. Signup for the webinar: https://bit.ly/4c1oi5p Learn more about Cloudbyz eClinical at info@cloudbyz.com #CTMS #eTMF #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #webinar