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🔍 Understanding FDA regulation: The ins and outs of medical devices! 💼💉 Join us as we delve into our latest blog post discussing the regulatory landscape of medical devices by the U.S. Food and Drug Administration (FDA). Explore key insights into the FDA's role in ensuring the safety and effectiveness of medical devices, as well as the regulatory requirements and processes involved in bringing these devices to market. 📖 Read more here: https://hubs.la/Q02q76zQ0 Stay informed about healthcare regulations and compliance. Don't forget to subscribe for more informative updates and valuable insights. 👍🔔 #FDAMedicalDevices #HealthcareRegulation #FDACompliance #PauboxBlog #StayInformed

Since the final FDA ruling on Laboratory Developed Tests was published on 06 May 2024, there has been a great deal of discussion around the interpretation and implications of the new oversight. The final ruling declares the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices under the Food, Drug, and Cosmetic Act (FDCA) and phases out the discretionary enforcement that has been in place since the law was first enacted in 1976. For 60 years CLSI has served as a trusted resource for laboratories, and we're here for them now – with the guidance, tools, and resources to ensure your lab is prepared. Download the report for more information about how to navigate these new requirements >> https://hubs.la/Q02-8RsG0. #LDT

How the Election Outcome could Impact FDA Regulations 🇺🇸 The upcoming U.S. election may bring significant shifts for the life sciences industry, with potential changes to FDA regulations and compliance requirements. A new administration could alter the pathway for medical device approvals and drug development, impacting how quickly and efficiently innovations reach patients. This is a critical moment for those of us navigating regulatory landscapes. Watch for insights on what these changes might mean and how companies can best prepare. #LifeSciences #Election2024 #FDARegulations #MedicalDevices #Compliance #HealthcareInnovation

The SFDA holds a crucial regulatory role, overseeing the Food, Drug, Medical Devices, and Operations sectors. With each sector managing distinct products under specific regulatory standards, the SFDA has faced many industry requests since its establishment. Particularly significant are queries regarding product classification as a drug, medical device, or food. Check out the Classification Decisions in SFDA in the image below. #SFDA #drugregulation #productclassification https://lnkd.in/dES_35pt

📰 The Food and Drug Administration (FDA) seeks input on health equity for medical devices to help shape a potential regulatory approach. This feedback will develop a framework for evaluating when devices should be tested in diverse populations to support their marketing authorization. The FDA's discussion paper is open for comments until October 4th. Learn more in this curated blog 👉 https://ow.ly/vxbt50TeBy5 #medicaldevice #fda

SUGAM serves several key roles within the regulatory framework: Application Submission: It allows for the electronic submission of applications for clinical trials, drug approvals, and licenses for cosmetics and medical devices . This digitization helps in reducing the paperwork and expediting the review process. Good Webinar on Sugam for Sites and Investigators Organized by ISCR on 15 November 2024. #iscr #Ctri #sugamportal #clinicaltrials #investigators #CRC #CRA.

FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled ...: FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices. U.S. Food and Drug Administration (FDA) ... http://dlvr.it/THC1Kz

Are you feeling overwhelmed by the regulatory complexities of Drug-Device Combination Products? With the MDR amending the drug legislation related to Combination Products, things can get confusing—particularly when it comes to Article 117. Join our free webinar on Thursday October 17, where my colleague Salma Michor will provide clear guidance and answers to your burning questions. Register to secure your spot! 👇 https://lnkd.in/eWSiUCfp #MDR #Article117 #CombinationProduct #MedicalDevice #DrugDeviceCombination

𝗙𝗗𝗔 𝗶𝘀𝘀𝘂𝗲𝘀 𝐟𝐢𝐧𝐚𝐥 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝗔𝗜-𝗲𝗻𝗮𝗯𝗹𝗲𝗱 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀 🤖🩺 : The U.S. Food and Drug Administration (FDA) has released guidance to provide recommendations for predetermined change control plans (PCCPs) in the context of AI-enabled medical devices. 𝗞𝗲𝘆 𝗣𝗼𝗶𝗻𝘁𝘀: ⏺ The guidance outlines how PCCPs can support iterative improvements to AI-enabled devices while ensuring their safety and effectiveness. ⏺ A PCCP should describe planned device modifications, methods for development and validation, and an assessment of their impact. ⏺ The FDA reviews PCCPs as part of marketing submissions to enable manufacturers to implement modifications without additional submissions for each change. ⏺ These recommendations apply to devices reviewed under 510(k), De Novo, and PMA pathways, including device-led combination products. 𝗪𝗲𝗯𝗶𝗻𝗮𝗿: 📅 On 14 January 2025, the FDA will host a webinar to provide further insights into the guidance. 👉 For more information, visit: https://lnkd.in/ewHYrQHG #ArtificialIntelligence #HealthcareRegulation #MedicalDevices #FDA #DigitalHealth

FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices https://lnkd.in/gui7WB8M Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle. Click here to view [...]