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The U.S. Food and Drug Administration has published new draft guidance on “Predetermined Change Control Plans for Medical Devices,” which describes the process by which device sponsors may seek FDA approval for modifications in advance by submitting a PCCP document, which would describe the anticipated changes and how they will be tested and implemented. We summarize this proposed policy in more detail here: https://lnkd.in/edNKsV2t #FDA #medicaldevices #PCCP Authors: Kelliann Payne and Suzanne Levy Friedman

Check out Kelliann Payne and my overview of FDA's recent draft guidance on PCCPs!

Today, the U.S. Food and Drug Administration (FDA) issued a draft guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. This draft guidance is an update to the current final guidance to propose clarification about how the FDA evaluates real-world data to be used in the FDA’s regulatory decision-making for medical devices. This draft guidance also proposes expanded recommendations to sponsors considering using real-world evidence to support regulatory submissions for medical devices. https://lnkd.in/eFM3Vey8

"Navigating the maze of medical device registration? Let GRA Pharma guide you! From understanding local regulations to compiling documentation, we'll help you smoothly navigate the process. Stay compliant, stay efficient with GRA Pharma! #MedicalDevices #RegulatoryAffairs #GCCJobs #GRAPharma"

📌 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟰-𝟮 𝗣𝗿𝗼𝗰𝗲𝗱𝘂𝗿𝗲𝘀 𝗳𝗼𝗿 𝘁𝗵𝗲 𝘂𝗽𝗱𝗮𝘁𝗲𝘀 𝗼𝗳 𝘁𝗵𝗲 𝗘𝘂𝗿𝗼𝗽𝗲𝗮𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗡𝗼𝗺𝗲𝗻𝗰𝗹𝗮𝘁𝘂𝗿𝗲 𝘛𝘩𝘪𝘴 𝘥𝘰𝘤𝘶𝘮𝘦𝘯𝘵 𝘭𝘢𝘺𝘴 𝘰𝘶𝘵 𝘵𝘩𝘦 𝘱𝘳𝘰𝘤𝘦𝘥𝘶𝘳𝘦𝘴 𝘧𝘰𝘳 𝘵𝘩𝘦 𝘢𝘯𝘯𝘶𝘢𝘭 𝘳𝘦𝘷𝘪𝘴𝘪𝘰𝘯 𝘢𝘴 𝘸𝘦𝘭𝘭 𝘢𝘴 𝘵𝘩𝘦 𝘱𝘳𝘰𝘤𝘦𝘥𝘶𝘳𝘦 𝘧𝘰𝘳 𝘢𝘥-𝘩𝘰𝘤 𝘳𝘦𝘲𝘶𝘦𝘴𝘵𝘴 𝘳𝘦𝘲𝘶𝘪𝘳𝘪𝘯𝘨 𝘢𝘯 𝘦𝘹𝘱𝘦𝘥𝘪𝘵𝘦𝘥 𝘳𝘦𝘷𝘪𝘦𝘸. https://lnkd.in/eFxg8x4z 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 for your time and please 𝗦𝗵𝗮𝗿𝗲, 𝗟𝗶𝗸𝗲 👍 and/or 𝗖𝗼𝗺𝗺𝗲𝗻𝘁. The European Medical Device Nomenclature (EMDN), as established by Article 26 of Regulation (EU) 2017/745 – Medical Device Regulation (MDR) and Article 23 of Regulation (EU) 2017/746 - In Vitro Diagnostic medical devices Regulation (IVDR), will be annually reviewed and updated based on the practical use of the EMDN and feedback from its users. 𝗖𝗼𝗻𝗻𝗲𝗰𝘁 𝘄𝗶𝘁𝗵 𝗺𝗲 𝗱𝗶𝗿𝗲𝗰𝘁𝗹𝘆 https://lnkd.in/ef6f65Ds or join the Quality Assurance & Regulatory Affairs group for all the current information. https://lnkd.in/eDK_F-Sb 𝙅𝙤𝙞𝙣 𝙖 𝙪𝙣𝙞𝙦𝙪𝙚 𝙜𝙧𝙤𝙬𝙞𝙣𝙜 𝙘𝙤𝙢𝙢𝙪𝙣𝙞𝙩𝙮 𝙤𝙛𝙚𝙭𝙥𝙚𝙧𝙩𝙨 𝘰𝘯 𝘵𝘩𝘦 𝙡𝙚𝙖𝙙𝙞𝙣𝙜 𝘔𝘦𝘥𝘛𝘦𝘤𝘩 𝘓𝘪𝘯𝘬𝘦𝘥𝘐𝘯 𝘯𝘦𝘸𝘴𝘭𝘦𝘵𝘵𝘦𝘳, 𝙎𝙞𝙢𝙥𝙡𝙚 𝙁𝙧𝙚𝙚 𝙎𝙪𝙗𝙨𝙘𝙧𝙞𝙥𝙩𝙞𝙤𝙣: https://lnkd.in/efh_KTK4 #medicaldevices #invitrodiagnostics #combinationproducts #mlv #qualityassurance #regulatoryaffairs #pharmaceuticals

New Blog: Navigating the FDA Submission Process for Medical Device Products: Six Helpful Reminders. #trinitymconsulting #regulatoryaffairs #medicaldevices #globalconsulting Submitting a medical device product to the U.S. Food and Drug Administration

Revvity Signals' latest blog explores the shift in FDA approvals and the rise of new drug modalities. 

Revvity Signals' latest blog explores the shift in FDA approvals and the rise of new drug modalities. Read the full blog post now: https://lnkd.in/gwgzzTxN

The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Remanufacturing of Medical Devices.” Although it mostly resembles the draft guidance, the FDA adds detailed examples and analyses of the regulatory requirements and considerations for “remanufacturers.” Read here for the analysis and guiding principles. #FDA

🌟 𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝘁𝗵𝗲 𝗙𝗗𝗔 𝗔𝗽𝗽𝗿𝗼𝘃𝗮𝗹 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗿𝘂𝗴𝘀 🌟 The FDA drug approval process is no walk in the park! From preclinical testing to post-market surveillance, compliance officers and life sciences companies must stay on top of rigorous regulatory standards to bring safe and effective drugs to market. 🚀 Understanding the key stages — from the IND application to clinical trials and the final New Drug Application (NDA) — is critical for minimizing delays and ensuring a smooth path to approval. 📋✅ 💡𝗥𝗲𝗮𝗱𝘆 𝘁𝗼 𝗺𝗮𝘀𝘁𝗲𝗿 𝘁𝗵𝗲 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗴𝗮𝗺𝗲? 𝗝𝗼𝗶𝗻 𝗼𝘂𝗿 𝗰𝗼𝗺𝗺𝘂𝗻𝗶𝘁𝘆 𝗳𝗼𝗿 𝗺𝗼𝗿𝗲 𝗶𝗻𝘀𝗶𝗴𝗵𝘁𝘀! https://lnkd.in/djsxij4j #ComplianceMatters #FDADrugApproval #LifeSciences #QorComply