Regulatory Affairs Professionals Society (RAPS)’s Post

Today, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health Center (CDRH) is releasing two medical device reports on safety and innovation – the two pillars of CDRH’s work to assure that patients in the U.S. have access to high-quality safe and effective medical devices. The “CDRH 2024 Safety Report” and “CDRH 2024 Innovation Report” provide summaries of CDRH’s accomplishments and look ahead to future initiatives. Learn more: https://lnkd.in/eVgFDsg6

Per the U.S. FDA’s CDRH Innovation Report 2024, partnering with patients and stakeholders is firmly among the Agency’s core pillars of advancing medical device safety and innovation. Some highlights from the report:    - patient-reported outcomes (PROs) included in 52% of authorisations with clinical studies, with 34% using PROs as primary and secondary endpoints - patient-centred research projects in diverse populations across 18+ disease/condition areas - patient engagement network with 20+ partner organisations - the establishment of the Patient Science and Engagement programme. The Agency is to continue building on these efforts. Its forward-looking plans include, among other steps, expanding partnering opportunities for all people to contribute to the evidence generation process for medical devices. More details: https://lnkd.in/g2ECucW9 #MedicalDevices #PatientEngagement #PatientCentredResearch #PatientScience #PatientReportedOutcomes #innovation

Medical devices provide amazing benefits to patients, but with that comes risk. The CDRH has released two reports detailing actions taken in recent years and goals for the future to assure the safety of medical devices keeps pace with the evolving technology. See the link in FDA's post below to learn more! #medicaldevices #patientsafety

🗣 The FDA Center for Devices and Radiological Health (CDRH) published a discussion paper all about health equity for medical devices. ⬇ Take a look to learn about the three factors that can help promote health equity in studies. #FDA #CDRH #ClinicalResearch #FDACompliance #QualityAssurance

📄 EPF supports the objectives of the European Commission's proposal to postpone the full application of the in-vitro diagnostic medical devices regulation, namely to ensure these devices remain available for patients.    While addressing potential shortages is critical for patients, so is the full implementation of a strengthened regulatory framework that ensures patient access to safe devices and promotes transparency. We call on all stakeholders to address the bottlenecks and work together to make it happen.    Last Tuesday, we attended the discussion on this proposal at the Medical Devices Coordination Group to make sure the #PatientPerspective is included. 👉 Read our full statement: https://bit.ly/42xneSS

🌟 Exciting News! 🌟   The EU is taking additional steps to ensure the availability of medical devices and in vitro diagnostics, prioritizing patient safety and public health. This includes allowing more time for manufacturers to transition to new rules, enhancing transparency and protecting patient care with the swift launch of the European Database on Medical Devices - #EUDAMED and obliging manufacturers to notify in case of supply disruptions. Together, let's prioritize patient care and safety in the healthcare sector!   Stay tuned for the latest updates by following our Turacoz Group page. https://lnkd.in/evGNmjt5   #TuracozGroup #MedicalDevices #PatientSafety #PublicHealth #Healthcare #EURegulations 🏥

Simplify your understanding of Semaglutide adverse reactions with Part 10 of our comprehensive series designed for medical providers. Visit [https://lnkd.in/gsn-ADKe] for additional resources. #SimplifyReactions #ComprehensiveSeries #10

📢 New version of MDCG 2021-6 - Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation has been published. This document is intended for sponsors of clinical investigations of devices conducted within the scope of the Regulation (EU) 2017/745 (MDR). PLease check the full text below 👇 #TUVNordPolska

In today's interconnected world, leveraging #reliance across regulatory systems emerges as a smart strategy, not only for conserving resources but also for improving availability to quality-assured medical products, regardless of a country's regulatory maturity. I was very glad to see that reliance was one of the main themes at the International Medical Device Regulators Forum in Washington DC last week, where regulators and industry from across the globe discussed the pursuit of reliance as a global objective to get devices to market more quickly and efficiently across jurisdictions. They also emphasized the need for clarity, consistency, and #trust among #regulatory bodies. At Roche, we are dedicated to advocating for significant reforms in regulatory policy to accelerate access for patients, and we actively support initiatives to operationalize reliance and encourage #globalcollaboration. Looking ahead, I hope reliance will evolve into a vital link between regulators and industry, fostering an environment fit for innovation that ultimately enhances more equitable access for patients.  #IMDRF Read more here: https://lnkd.in/g9MgH8kC

Good Morning, Sydney! Looking forward to attending the ARCS Australia Annual Conference this week (12th - 14th June 2024) to hear the latest in medical device regulation. Excited to connect with industry experts and learn about the new advancements in our field. See you there! #ARCSAustralia #MedicalDevices #MedTech #RegulationUpdate #HealthcareInnovation #SydneyEvents #MedicalConference #IndustryExperts #HealthcareAdvancements #TechInMedicine