RAPS Chicago Chapter’s Post

[FREE WEBINAR] 12 pm ET, September 12. The FDA submission process is full of hurdles, but insider tips can help you clear them with confidence. In this exclusive webinar, led by a former FDA reviewer, you'll gain insider knowledge and practical strategies to ensure your submission stands out for all the right reasons. Whether you're a seasoned professional or new to the process, you'll learn actionable insights that will help you avoid costly delays and position your device for a successful review and approval. Register at this link: https://bit.ly/3Z5myEN. #webinar #fda #medicaldevices #submission #greenlightguru #medtech

MEDIcept Minute: NOW AVAILABLE: Voluntary Use of eSTAR for 513(g) Requests for Information Exciting news alert! The FDA's electronic Submission Template And Resource (eSTAR) is now available for voluntary use for 513(g) requests for information to CDRH. This interactive PDF form guides applicants through preparing a comprehensive medical device submission, ensuring quality and completeness. As we continue to navigate the dynamic landscape of medical device regulation, tools like eSTAR become invaluable for efficient premarket reviews. Read more about this announcement from FDA at the link below: https://lnkd.in/gEg8p-jP At MEDIcept Inc., we're committed to supporting industry professionals in staying ahead of regulatory advancements. Contact sales@medicept.com TODAY for expert advice tailored to your needs. Let's elevate the standards of medical device submissions together! #FDA #MedicalDevice #RegulatoryCompliance #eSTAR #MediceptAdvice  

Have you completed this MedTech Intelligence survey on "Managing #MedicalDevice Regulatory Strategy & Compliance"? Make your voice heard! Your participation will help identify regulatory gaps, outsourcing processes and new technologies.

Any human clinical testing lab providing testing internationally should put this on the radar! It’s Free…and with virtual options! With members regulators, over half of which have LDT rules & testing/genetic testing rules AND are MDSAP members: Australia Argentina Brazil Canada China EU UK Singapore Japan South Korea and United States Even for those jurisdictions that separate IVDs and other medical devices, the insights to global device harmonization are here

One effective way to reduce risk of questionable lab data is to use an ISO 17025 accredited lab and make sure that each of the testing methods the lab is performing for your company are listed on the labs 17025 certification. This ensures a lab specific quality system is in place and the accreditation body has evaluated the lab and each of the tests listed on the labs certification. If the above is missing, it’s probably important to look for an alternative lab for your testing needs.

Last week, the FDA sent a 477-word letter to medical device manufacturers, reminding them to review 3rd party data. Here are 4 actionable takeaways if you are a sponsor or device manufacturer: --- P.S. What other tips would you add to help sponsors and medical device manufacturers manage third party data?

FUN FACT FRIDAY!! FDA's Center for Devices and Radiological Health (CDRH) initiated the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot to enhance the premarket review process for breakthrough medical devices. The TAP Pilot aims to foster early engagement between device sponsors and the FDA, improve the quality of submissions, and streamline the review process by addressing potential issues proactively. This program is part of the FDA's broader efforts to modernize the medical device regulatory framework and ensure that safe and effective devices reach patients more efficiently. The agency recently announced plans to expand the program. Learn more here: https://lnkd.in/ewic_5Qj #regulatory #regops #eCTD #submissionready

Stronger clinical data solves a lot of problems for medical device manufacturers. Why? Nearly every challenge from getting regulatory approval and reimbursement to marketing the product can be addressed with stronger clinical data. No, clinical data is not the only requirement for a successful medical device. But without strong clinical data, it's hard to get anywhere, especially, in a world of tightening reimbursement, increasing competition - especially from emerging manufacturers in new markets, and growing demand for healthcare across the developed world. Real World Data is easier to generate than ever before, but data is like oil, the value comes in refining and processing it to create value. IQVIA is a global leader in Real World Evidence generation. The Real World Solutions business is hosting a free webinar on the topic of RWD/RWE for regulatory submissions. Details below:

Real World Data (RWD) can enhance the safety and effectiveness of medical devices, but the quality controls differ from those of traditional clinical studies. In our upcoming webinar, we delve into the specifics of the recently released FDA draft guidance that provides considerations for evaluating the relevance and reliability of RWD for regulatory decision-making. Register now. https://bit.ly/3Vcfwud #RWD #medicaldevices

“Dr. Jeff Shuren, FDA CDRH Director, to Retire.” Read our latest Medical Device Blog post by Zach Messick here: https://lnkd.in/gYDq5VpC   #KnobbeMartens #IPLaw #MedicalDevice