Medtech & Pharma Platform Association’s Post

While the recent FDA Final Rule related to In Vitro Diagnostics and Laboratory Developed Tests has sparked concerns around enforcement risk, cost, and compliance burden for manufacturers, in our latest whitepaper we also highlight the hidden market access opportunities for IVD developers that are quick to adapt. Our experts Nayan Ghosh & Emma Feinerman draw parallels to a similar guidance around in vitro companion diagnostics released a decade prior, when companies like Foundation Medicine & QIAGEN saw favorable, product-specific coverage determinations by proactively pursuing FDA premarket review ahead of their LDT competitors. Request a full copy here: https://lnkd.in/eptbRN73

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.

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

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

📢 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

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

🌐 Webinar Series showcase: IVD Reagents Registration Requirements – China & US Perspectives 🌍 Explore the general regulatory landscape of IVD reagent, non-clinical/clinical documents, registration of CDx reagents and the FDA's interpretation of medical device classifications. The content of this video includes the changing regulatory landscape in both China NMPA and US FDA for In Vitro Diagnostics (IVD) reagents. Specifically, the online seminar will show the key requirements, processes, and approval criteria for reagent products in these 2 largest Medtech markets in the world.    🔎 Watch the short clip for key takeaways and download the full recording through the link below to deepen your understanding：    https://lnkd.in/eJCyU7PH 📩 Please email us at info@Chinameddevice.com to set up a complimentary call if you have any questions. Feel free to ask our experts how we can suggest market access for your individual needs.    #MedicalDevice #Healthcare #FDA #NMPA #ChinaMarket #USMarket #CostOpimization #MarketAccess #IVD #IVDReagent #VitroDiagnositics #CDx #CDxReagent #FDAClassification   

🌟 Insights from the November 2024 FDA IVD Roundtable 🌟 The FDA IVD Roundtable brought valuable updates for innovators in the in vitro diagnostics (IVD) space. Here are some key highlights: 🔑 Dual 510(k) and CLIA Waiver Submissions: Navigating dual submissions requires addressing common pitfalls early, including robust risk analysis, clearly defined testing sites, and setting appropriate statistical thresholds like ATE and LER. Simpler device designs make for smoother CLIA waiver approvals. 🔑 Emergency Use Authorization (EUA): With COVID-19 diagnostics shifting to 510(k) pathways for market stability, EUAs remain critical for emerging health threats like Mpox. Understanding the FDA’s dynamic prioritization process is essential for swift authorization. 🔑 Breakthrough Device Designation (BDD): Timing is key—premature submissions without solid evidence of clinical success and technical feasibility often face delays. Demonstrating transformative potential and patient benefits can accelerate review. 🔑 Reclassification of High-Risk IVDs: The FDA is reclassifying some Class III devices (e.g., HBV and CMV assays) to Class II based on evidence of moderate risk. This shift streamlines approvals, encourages innovation, and expands patient access. These insights reflect the FDA’s evolving approach to IVD regulation, emphasizing efficiency and public health responsiveness. 💡 Staying informed is critical in a fast-evolving landscape. A big thank you to the FDA for fostering dialogue with stakeholders and to all participants driving innovation in IVD! #IVD #Diagnostics #FDA #RegulatoryAffairs #Innovation #Healthcare https://lnkd.in/gX_Bs8_6

🔬 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

MEDIcept White Paper: First Quarter 2024 Clinical 483 Inspection Observations are Tracking to 2023 Trends. How to Stay Ahead with a Winning Strategy! 2023 Clinical 483 Inspection Observations Trends Are you curious about different ways to avoid a 483 violation? Then this MEDIcept Inc. White Paper is for you! Each year, FDA compiles a list of 483 inspection observations into a dataset, summarizing ways companies have violated FDA regulations throughout that fiscal year (FY). In fiscal year 2023, there were 720 observations issued for medical devices, 45 for biologics, 96 for human tissue for transplantation, and 158 for bioresearch monitoring included in the dataset.  In this paper we present the top 6 clinical inspection observation trends identified in FY 2023; which section of the federal regulations were violated; and how sites, sponsors, and/or contract research organizations (CROs) can implement strategies to minimize the possibility of receiving a 483 violation when an FDA inspector knocks on their door.  Click the link below to read the White Paper written by Elizabeth Braschayko, MS, Clinical Project Manager, and Emily Sawtell, Associate Medical Device Consultant. https://lnkd.in/eQfrw-rG Do you want to start implementing strategies to avoid regulatory non-compliances and findings, but you are not sure where to start? MEDIcept has an experienced CRO who would be glad to assist you. Reach out to us today at sales@medicept.com to get started! #clinicaltrials #CRO #483violation #FDA #observation #trends #medicaldevices #whitepaper