Genesis Logistics’ Post

The New In FDA Welcome to Device Advice, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) web page for comprehensive regulatory education. Device Advice is CDRH's premier text-based resource that explains medical device laws, regulations, guidances, and policies, across the entire product lifecycle https://lnkd.in/gcMN-3SD #fda #fdaapproval #fdacompliance #fdaregulations #regulatory #regulations #regulatoryaffairs #regulatorycompliance #medicaldevices #medicaldevice

It was a treat to talk with Lizzy Lawrence at STAT about draft FDA guidance documents related to potential changes to the FDA 510(k) program. The proposed guidance documents are an excellent example of evidence-based regulatory policy and builds on recent work by me and my colleagues Yi Zhu (who is on the job market this year!), Pinar Karaca-Mandic, Soumya Sen, and Ariel Dora Stern in JAMA earlier this year, along with other important empirical work. https://lnkd.in/gNszpfhF At the same time, there's only so much that can be done while still operating within the existing parameters of the 510(k) process and our current data infrastructure. I have some more thoughts on changes to 510(k) and post-market surveillance over on the bad website (X/Twitter): https://lnkd.in/g7xVQY5M

Understanding the importance of regulatory compliance in the medical device industry is crucial for ensuring patient safety and product efficacy. Regulatory bodies like the FDA, EMA, and others set rigorous standards to protect public health and ensure devices perform as intended. At ND Global, we prioritize compliance with these regulations to deliver safe and reliable medical devices. Our commitment to robust quality management systems, continuous monitoring, and adherence to international standards underscores our dedication to excellence and innovation in healthcare. #MedicalDevices #RegulatoryCompliance #PatientSafety #QualityManagement #HealthcareInnovation #NDGlobal

In 1980, Genesis sang, “There must be some misunderstanding.” Last month, FDA and a medical device company had a misunderstanding of their own, which resulted in the agency issuing the company a Warning Letter that waded into the enforcement area of medical device versus Medical Device Data Systems and Clinical Decision Support Software. In light of the letter, my colleague Priya Sinha and I recommend that companies review their product labeling, promotion, and other product attributes to evaluate a product’s regulatory status. Learn more in our latest Bulletin.

FDA issued draft guidance on manufacturer communications to healthcare professionals about scientific information on unapproved uses of approved or cleared medical products. Sara Simon and Alicia Whittlesey share insights on the 'dos' and 'don'ts' for these vital communications. #LifeScience #FDA #MedicalProducts #Healthcare

📅 Mark Your Calendars! Well, not really, we don't have specific days to mark, BUT it's always exciting to see that there will be lots of interesting reading to be done in the coming year when it comes to #medicaldevice Guidance from the FDA 📖 These documents always give us so much to think about and raise important questions surrounding how we can all make safer and more effective medical devices. https://lnkd.in/e5PJyaru Which article are you most excited about?! (<--literally the nerdiest thing we've ever said 😂)

So much in common, Yet different! Though both aim to improve human health, #medicaldevices and #biologicalproducts have distinct regulatory pathways within the FDA. Medical devices 🌡 are primarily regulated based on risk assessment, with varying levels of scrutiny depending on their potential risk. On the other hand, biological products 💉 often require a more rigorous and comprehensive approval process, including extensive safety and efficacy testing. Here are some of the major differences when starting to talk about medical devices and biological products from an FDA regulatory perspective. ❓ What other regulatory differences between medical devices and biological products would you add? Share your thoughts in the comments below! ⬇

Giving the FDA feedback has never been easier. 💬 Stay tuned and expand to read more. The United States Food and Drug Administration (FDA) is actively asking for feedback towards the modernization of the Premarket Notification [501(k)] program. The FDA has released new guidelines to provide us with the clarification we need to provide the utmost safety towards medical devices. This allows a pivotal component of the FDA’s commitment to enhance the framework of governing medical devices. Wanna know how to comment? Check the comments below! ✅ Follow us: iYou Health ✅ Check out our website at: www.iyou-health.com #iyouhealth #clinical #clinicalstudies #research #medical #medicaldevices #feedbackmatters #fda

🎉 Excited for the coming months as we're rolling out a series of videos 🎥 showcasing the excellence of compounded medications at Town & Country Compounding Pharmacy! 🚀 1️⃣ First up, don't miss this enlightening video where I do standup with John Herr, the founder of TCC, to tackle the GLP-1 shortage conversation. 🎤💡 2️⃣ Next, be sure to follow the Town & Country Compounding Pharmacy page so you won't miss out on our weekly video drops! 🔔 And, here's a little spoiler: we've got an amazing series with Viral Jani, Pharm D titled "Going Viral with Viral!" 🌟 (Yes, we love a good pun 😄) 3️⃣ Finally, to dive deeper into compounded GLP-1 medications, visit this link: https://lnkd.in/eKzUpftV Have questions? Feel free to email me at smalen@tccompound.com or schedule a call with me at www.tidycal.com/stevetcc 📧📞 Stay tuned and engage with our content for more insights and updates! #CompoundedMedications #PharmacyInnovation #Healthcare #GLP1Shortage #Pharmaceuticals #TownAndCountryCompounding

Interesting reading on what the FDA have planned for new and final guidance documents for medical devices in 2024! Looking forward to seeing more on  “Predetermined Change Control Plans for Medical Devices” https://lnkd.in/eYaTnjFr #FDA #Medtech