MAE Group LLC’s Post

𝗨𝗻𝗱𝗲𝗿𝘀𝘁𝗮𝗻𝗱𝗶𝗻𝗴 𝘁𝗵𝗲 𝗙𝗗𝗔 𝗤-𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗣𝗿𝗼𝗴𝗿𝗮𝗺 Q-Submission Program is a mechanism available to submitters through which they can request interactions with the FDA related to medical device submissions. These interactions can include written feedback and/or a meeting related to potential or submitted medical device.  𝐁𝐞𝐧𝐞𝐟𝐢𝐭𝐬 𝐨𝐟 𝐭𝐡𝐞 𝐐-𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐏𝐫𝐨𝐠𝐫𝐚𝐦: • Understand the FDA's perspective on your device's development and regulatory strategy. • Resolve questions about data requirements, clinical studies, and more before committing resources.  • Increase efficiency by addressing FDA concerns upfront, potentially shortening review times 𝐓𝐲𝐩𝐞𝐬 𝐨𝐟 𝐐-𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧𝐬: • Pre-Submissions: It is a request for FDA feedback prior to an intended premarket submission (IDE, PMA, HDE, De Novo request, 510(k), CW, Dual, Accessory Classification Request, BLA, or IND). • Submission Issue Requests (SIRs): It is a request for FDA feedback via written feedback or a meeting on a proposed approach to address issues conveyed in a marketing submission hold letter, a CW hold letter, an IDE Letter, or an IND Clinical Hold letter. • Study Risk Determinations: It is a request for FDA determination for whether a planned medical device clinical investigation is significant risk (SR), nonsignificant risk (NSR), or exempt from most requirements under the IDE regulations. • PMA Day 100 Meetings: It is a FDA meeting held within 100 days of receiving a PMA application, allowing discussion on its review status as requested by the applicant. • Other Q-Submission Types:    1. Agreement and Determination Meetings    2. Submissions associated with Breakthrough Devices Program   3. Submissions associated with Safer Technologies Program    4. Accessory Classification Requests • Informational Meetings: It allows for sharing information with the FDA without expecting feedback. It is used to establish interactions not covered by specific Q-Sub types. At MAE Group, we specialize in guiding medical device innovators through the complexities of FDA regulatory processes. Our team of experts can assist you in navigating the Q-Submission process, ensuring your submission is well-prepared and aligned with FDA expectations. Ready to streamline your FDA journey? Connect with Darshan Bhaiya, our Regulatory Affairs Specialist at darshanb@maegroups.com to learn how MAE Group can support your regulatory needs.  Visit our website: https://lnkd.in/dX-QT9_2 Read the Q-Submission guidance here: https://lnkd.in/gJEa6RTp Stay tuned to learn more about the intricacies, and nuances associated with a Pre-submission meeting request with the FDA in our upcoming post. #FDARegulation #MedicalDevices #FDAConsulting #RegulatoryStrategy #QSubmissionMeeting

Happy National Dentist Day! Today, we give a big shoutout to the heroes of oral health - our dentists! Thank you for keeping our smiles bright, our teeth healthy, and for all the care and dedication you put into every check-up and treatment. Remember to show some love to your dentist today, whether it's a thank you note, a social media shoutout, or simply scheduling your next visit. Let's celebrate by committing to good dental hygiene and appreciating those who help us maintain it. Did you know the medical devices used by Dentists have to go through rigorous FDA inspections and testing? MEDVACON provides expert assistance in ensuring these devices pass these tests and inspections. Learn more about how we contribute on our website! https://lnkd.in/epNBXYHK #discovery #lifescience #pharma #pharmaceutical #pharmaceuticals #biopharma #biopharmaceuticals #biopharmaceutical #biotech #biotechnology #biotechnologies #biotechindustry #biotechnologyindustry #pharmaceuticalindustry #pharmaceuticalmanufacturing #pharmaceuticalcompanies #pharmaceuticalresearch #pharmaceuticaltechnology #pharmaceuticalpackaging #pharmaceuticalsales #pharmaceuticaljobs #pharmaceuticalinnovation #pharmaceuticalsciences #biotechnologist #compliance #qualitycontrol #computersystemvalidation #cleaningvalidation #processvalidation #dataintegrity #technologytransfer #meddevice #medicaldevice #medicaldevicemanufacturing #medicaldeviceindustry #medicaldeviceregulation #medicaldevicemanufacturing #medicaldevicesales #medicaldevicedevelopment #medicaldevicedesign #medicaldeviceresearch #laboratoryequipment #laboratories #laboratorymedicine #laboratoryservices #laboratoryprofessionals #capa #qualification #validationengineer #engineering #engineeringservices #engineeringsolutions #processengineering #processengineer #engineeringdesign #heretohelp #gettingthejobdone #gettingthingsdone 

Understanding regulatory requirements is essential for medical information professionals, especially when it comes to product labeling. One critical regulation to know is CFR Title 21 Part 201, which outlines the requirements for labeling human prescription drugs and biological products. Here’s what you need to know: • What is CFR Title 21 Part 201? This regulation establishes the standards for drug labels, ensuring they are clear, accurate, and informative for healthcare professionals and consumers alike. • Why It Matters for Medical Information Professionals: Accurate labeling directly impacts how we communicate with healthcare providers and consumers. Being well-versed in these regulations helps ensure the information we convey aligns with FDA requirements, maintaining compliance and protecting patient safety. • Your Role in Ensuring Compliance: Whether drafting product information or responding to inquiries, having a solid grasp of CFR Title 21 Part 201 empowers us to provide clear, compliant, and effective communication. This is just the tip of the iceberg when it comes to labeling regulations. As medical information professionals, staying informed helps us enhance the quality of our interactions and strengthens the trust we build with our stakeholders. #LifeSciences #Pharma #Biotech —————— 🔔 Follow me here on LinkedIn for clear, concise insights into the life sciences. I post three times weekly! 📩 Subscribe to my monthly newsletter for deeper dives into topics important to the medical information space.

💡What is Dossier Documents in Medical Device?💡 📌 Dossier Documents is a complication of documents that are submitted to the regulatory authorities to seek market approval 🗒 These contains the comprehensive documents like a)     Design and Development b)     Manufacturing Process c)     Clinical Data d)     Labelling e)     Instruction of Use 📌 The Dossier Documents may vary depending on the regulatory requirements of the country or region 📎 Example 📎 📋 For European Union: It includes technical file or design dossier, clinical evaluation report and other relevant documents according to the requirement of MDR or IVDR 📋 For United States: It includes premarket submission to Food and Drug Administration (FDA) such as 510(k) submission, premarket approval or De Novo classification request.

FDA Classification The FDA (Food and Drug Administration) classifies medical devices into three classes based on the level of control necessary to ensure the safety and effectiveness of the device. The classification of your device defines the type of Premarket Submission necessary for FDA approval to market the device in the U.S. For devices classified as Class I or II that are not exempt, a 510(k) submission will be required for marketing. For devices classified as Class III a PMA will be required. For each Class the FDA determines different regulatory control. 🔹 General controls are regulatory requirements authorized by the FD&C Act, under sections 501, 502, 510, 516, 518, 519, and 520. 🔹Special controls shall include: Performance standards, Postmarket surveillance, Patient registries, Special labeling requirements, Premarket data requirements and Guidelines. At OLKON, we can navigate you through all the classification processes and ensure it meets all regulatory requirements! If you need more information about this topic you can contact us via sales@olkon.tech. #OLKON #Medicaldevices #FDA

FDA 510(k) Submissions & Market Approval 🏅 📑 Mastering FDA 510(k) Submissions & Market Approval 🏅 Navigating the FDA 510(k) submission process is crucial for getting medical devices into the U.S. market. I specialize in preparing and managing 510(k) submissions, ensuring compliance with FDA requirements, and accelerating the approval process. 🌍 Key Skills & Expertise: 🔹 FDA 510(k) Submissions – Preparing detailed and accurate documentation for FDA 510(k) submissions, ensuring compliance and fast approval. 🔹 Market Authorization – Helping companies gain market authorization for medical devices, ensuring adherence to U.S. regulations. 🔹 FDA Regulatory Requirements – Understanding and applying FDA regulations to streamline the approval process for your products. If you need guidance on your FDA 510(k) submission or want to discuss the regulatory approval process, I’m here to help! 📧 Contact me at: 💬 WhatsApp: +919413846660 📧 Email: workfordhandiadeepak@gmail.com 🔗 LinkedIn: https://lnkd.in/g99kDvPW #FDA510k #MedicalDeviceApproval #MarketAuthorization #FDARegulations #RegulatoryAffairs

Are you up to date with the latest MDR regulations? Turacoz has released a crucial article detailing how MDR regulations affects the packaging of medicinal products that include medical devices. From compliance strategies to labelling solutions, this guide covers it all! 👉 Dive into the details and ensure your packaging strategies are compliant! Read more here: https://lnkd.in/gMRUzDZp For inquiries, reach out to us at 📧 info@turacoz.com #MedicalDevices #Healthcare #Regulations #PharmaIndustry #Compliance #Turacoz

Exciting developments in FDA regulations for medical device manufacturers! The FDA has expanded its inspection guidance to enhance safety and quality standards across the industry. This updated framework aims to ensure compliance and streamline processes for device manufacturers. Read more about the implications of this FDA law update in the article below: #FDA | #MedicalDevices | #RegulatoryCompliance |#HealthcareInnovation

💡𝐊𝐞𝐲 𝐓𝐚𝐤𝐞𝐚𝐰𝐚𝐲𝐬 𝐟𝐫𝐨𝐦 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐁𝐞𝐬𝐭 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞𝐬 𝐟𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐂𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 As #regulatory demands for medical device suppliers continue to rise, the need for streamlined processes and efficient content management has never been greater. In a new PharmaTimes Media Ltd article, Sonia A. Veluchamy, Our CEO, shares insights into how pharma’s regulatory strategies could hold valuable lessons for the #medicaldevice industry.   Discover how a proactive approach to regulatory information management (RIM) and leveraging automation can help optimize #compliance efforts.   🔗 Read the full article here: https://lnkd.in/gE69zhNP   #RegulatoryAffairs #MedicalDevices #Pharma #RIM #LifeSciences #MedTech #Automation

"Thrilled to announce the completion of an advanced program in Regulatory Affair ..! ✨🎉 Equipped with comprehensive knowledge of regulatory processes, compliance, and industry standards. Over a month we covered key points including IND, NDA,CTD,eCTD ,GMP,GLP , Regulatory frameworks approval process for cosmetics , medical Devices clinical trial regulations, additionally regulatory submission and strategies for different types of products , emerging trends and future development in Regulatory affairs,Let's connect to explore how I can contribute to your organization's success!"🤝