Mark Von Eisenburg, MS’ Post

The FDA’s decision to regulate LDTs as medical devices brings numerous uncertainties to the field, but #AvalereExperts are here to help stakeholders parse through what the new rule means for them. Read our latest analysis on phaseout requirements, recent clarifications on implementation, and next steps for manufacturers of in-vitro diagnostics marketed as LDTs: https://lnkd.in/eQ2adjif Interested in learning more about the changing landscape of lab developed tests? Connect with one of our seasoned experts in regulatory strategy, evidence, and market access today: https://lnkd.in/eihYvhDm Caroline Williams, Mark Von Eisenburg, MS, Nancy El Hoyek, Laura T. Housman, MPH, MBA, DrPH(c), Brigit Kyei-Baffour, MBA #LDT #LDTs #labdevelopedtests #diagnostics #marketaccess

CDRH 2024 Reports Highlight Steps to Keep Up With New Technology, Ensure Safety: The FDA’s CDRH 2024 safety and innovation reports tout how the center has updated its 2018 Medical Device Safety Action Plan and regulated evolving technologies while working to make the U.S. market more innovative for devicemakers. #fda #financial #lifesciences

Medical Devices Need Top Priority in Supply Chain, Conference Speakers Say: Within the supply chain universe, medical technology and its countless components needs to stay front and center when competing with other industries, emphasized the FDA’s lead officer on the subject during a two-day workshop on generic drug-device combination products last week. #fda #financial #lifesciences

🏥 𝗨𝗻𝗱𝗲𝗿𝘀𝘁𝗮𝗻𝗱𝗶𝗻𝗴 𝗶𝗻-𝗵𝗼𝘂𝘀𝗲 𝗜𝗩𝗗 𝗱𝗲𝘃𝗶𝗰𝗲𝘀 👨🔬 The regulatory framework for in-house IVD devices under IVDR offers a unique blend of flexibility and structure, fostering innovation and tailored solutions in the MedTech landscape. This pathway enables rapid adaptation to emerge needs and enhances diagnostic capabilities, providing significant opportunities for medical laboratories and health institutions to lead in developing cutting-edge diagnostics. 𝗔𝗿𝗲 𝘆𝗼𝘂 𝗽𝗿𝗲𝗽𝗮𝗿𝗲𝗱 𝘁𝗼 𝗹𝗲𝘃𝗲𝗿𝗮𝗴𝗲 𝘁𝗵𝗲 𝗳𝗹𝗲𝘅𝗶𝗯𝗹𝗲 𝗮𝗻𝗱 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝘃𝗲 𝗼𝗽𝗽𝗼𝗿𝘁𝘂𝗻𝗶𝘁𝗶𝗲𝘀 𝗼𝗳𝗳𝗲𝗿𝗲𝗱 𝗯𝘆 𝘁𝗵𝗲 𝗜𝗩𝗗𝗥 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗽𝗮𝘁𝗵𝘄𝗮𝘆 𝗳𝗼𝗿 𝗶𝗻-𝗵𝗼𝘂𝘀𝗲 𝗜𝗩𝗗 𝗱𝗲𝘃𝗶𝗰𝗲𝘀? ⁣ #CMGMedDev #in-house #IVD #MedTech #RegulatoryCompliance #Diagnostics #Medicallaboratories #Laboratory #Health

Here I provide a brief insight into the in-house IVD regulatory pathway! Please do not hesitate to contact us if you need any guidance. #IVD #IVDR #MedTech #clinicallaboratory #laboratory #health #regulatory #CMGMedDev

🌏Accel Groups is proud to partner with Shanghai High End Medical Equipment Industrial Park to help 100+ MedTech manufacturers understand FDA requirements. We will jointly launch an online live webinar at 14:00 pm China time on July 23, 2024 - "FDA Breakthrough Device Designation (BDD) and Safer Technologies Program (STeP) Application". 💡 This webinar will provide a detailed introduction to the background, purpose and importance of the FDA Breakthrough Device Designation (BDD) and STeP programs, master the specific requirements and application process of BDD and STeP, share tips and best practices for writing application documents, and answer common questions. Medical device manufacturers are welcome to join! Registration here: https://lnkd.in/dbN_NmHH 🤝Accel team of experts will help you avoid common mistakes and ensure that your application is approved in a timely and efficient manner. We also provide comprehensive support for the Breakthrough Device and STeP programs to ensure that your product can be successfully launched. ✨ If you have any questions about the Breakthrough Device Program and the Safer Technology Program (STeP) submission, please feel free to contact us at info@accelgroups.com to schedule a complimentary call with us. #FDA #USmarket #webinar #regulatoryaffairs #clinicalaffairs #BDD #STeP

Discover new pathways to professional success with the Drug and Medical Device Development: A Strategic Approach program from #MITxPRO and gain insights on strategies that drive success in today's competitive landscape. Join the program now: https://lnkd.in/daEWwddu #MITxPRO #ExecutiveEducation #DrugDevelopment #MedicalDevice #Biotech #HealthcareInnovation

📍#Inhousedevice (#LDT in #US), and especially in-house #IVD, play a prominent role in #personalizedmedicine and are a fundamental part of our #innovation. These developments must be the same as the rest of safe and effective #MD #IVD #MDSW, so they are not exempt from #regulatory needs, being more relaxed than those necessary in commercial devices. ▶️ Do you neef help? Do you need to develop and implement #ISO15189 for your in house IVD? Are you thinking on #Verify and #validate your laboratory methods? We are experts and we help you. Contact us ! CMG MedDev #quality #regulatory #medicaldevice #invitrodiagnostic #EU #clinical #analytical

Medical Device and IVD manufacturers are facing a significant deadline on 26 May 2024 🚨 The upcoming CPD Certified Professional Development training course, endorsed by Medilink Midlands, will help to ensure that you're prepared for this transition 👏🏼 Delivered by Medilink Midlands member IMed Consultancy Ltd, this course will prepare you for the Medical Device Regulation Transition by helping you to understand whether it may be right for your business to make the decision to (re)certify your medical devices for sale in the EU 🌎 Manufacturers who have not made a decision to transition their medical devices to meet the requirements of the new European Union regulations will not be legally able to continue selling their products into the European Union (and potentially other markets including the UK) - so make sure you book your place before spaces get filled! ⏰ Medilink Midlands members receive a discount on this course too 🌟 Find out more and register here https://lnkd.in/eYHaw-EA #regulations #support #innovation #medtech #healthtech #cpdaccredited

Paul Piscoi shared at the CRONOS Event the status of #EUMDR: status and latest developments. Key points to remember: 1. Number of notified bodies is increasing and we can expect more to come this year 2. Clinical evidence remains an issue which requires measures towards ensuring better understanding of the expectations on the various devices 3. 106 Guidance Documents are available to help on understanding the legal text 4. The regulation transition periods were adopted many times 5. EUDAMED will be implemented gradually to ensure early and better transparency 6. Many activities are happening at the #MDCG and with the support of #ExpertPanel to support #Orphan Devices 7. 12 Expert Panels are available for medical devices and in-vitro diagnostic devices. The screening panel does the selection of #CEAR for Opinion. So far, 110 files were submitted and just 13 opinions were provided. For the IVD 21 files were submitted and 19 views were delivered; 2 are still ongoing. 8. Advice to manufacturers is still in the pilot phase. 39 letters of interest in total. 10+1 manufacturers were selected for an advice. Jens Fiehler, Christian Taschner, Adnan Siddiqui, MD, PhD