Understanding Real-World Evidence for Medical Devices

In this Issue

From the Editor ✍🏽 | In Brief 💥 | Webinar 🎙️ | Featured Session 📌 | Sections ✅ | Postscript 🐝

From the Editor ✍🏽

Aside from all the wonderful connections, some highlights from RAPS Convergence for me included attending the Notified Body Forum, the RWE session featured below, and a one-on-one interview with Amelia Hufford, co-founder of 3Aware about Finding a Sustainable Path Forward in Medical Device Regulation.

🔥 PLUS, 13 super-useful new posts and Martin King's Regulatory Roundup!

In Brief 💥

The final IMDRF Document Implementation Report was summarized by Stefano Bolletta

Marina Daineko underlined how to protect against fraudulent test data with the ASCA process

6 reasons to integrate GSPRs early were overviewed by EU MDR Compliance

The role of device registers and databanks under Article 108 of the MDR was explained by Tibor Zechmeister

J. David Giese commented on the FDA’s clearance of a new SaMD for sleep apnea from Apple

A new handout on the classification and grouping of medical devices was published by Zafar Zahid, PE

Sujeet Katiyar published an interesting article on the state of SaMD in India

The importance of working on CER throughout the testing process was highlighted by PRO-LIANCE GLOBAL SOLUTIONS GmbH

John Lafferty published a list of his top 10 deficiencies in CAPAs

Zamann Pharma Support posted a useful guide to comparing global medical device regulation

An article titled “Medical Devices 101: An Entry Level Overview of the FDA” was published by Michelle Lott, RAC

Sidika Karakas shared how she explains HgBA1c to patients in a helpful post

Parul Chansoria explained health care innovation trends in a new infographic

Featured Webinar 🎙️

Click to Register for FREE

Join the more than 800 registrants for our upcoming webinar, Clinical Data Requirements: EU vs. US – Critical Differences and Strategies, with moderator David Filmore, and expert speakers Maria E. Donawa, M.D., President of Donawa Lifesciences, and Dr. Tom Melvin, Associate Professor of Medical Device Regulatory Affairs at Trinity College Dublin.

Featured RAPS Session 📌

Fit for Purpose: Real-World Evidence at RAPS Convergence

At the RAPS Convergence, I attended a lively session on real-world evidence (RWE) for medical devices, led by William M. Sutton, Vice President of North America at Tianjin Mid-Link Biomedical Technology Group. Sutton discussed the evolving landscape of using real-world data to support regulatory decision-making for medical devices. The focus was on FDA’s current and draft guidance, emphasizing the crucial need for RWE to be “fit for purpose”—relevant and reliable—when used in regulatory submissions.

Carrie Britton, who was present in the audience, contributed greatly to the discussion by highlighting practical challenges and opportunities in leveraging real-world evidence. Her insights on addressing bias in data collection and maintaining data integrity added depth to the conversation about how RWE can help reduce the burden of traditional clinical trials while still meeting stringent regulatory standards.

After the session, I had the chance to meet one of the guidance document’s authors, Mary Beth Ritchey, who provided a deeper understanding of the ongoing efforts to make RWE more applicable and acceptable for regulatory purposes. Together, these discussions point toward a future where real-world data plays a vital role in expediting the approval of safe, effective medical devices.

510(k) Roundup

Click to View this week's 510(k) Roundup and Subscribe for FREE

Congratulations to this week's 59 new 510(k) clearances, including 20 companies (indicated by 🚀) that were granted their first 510(k). Subscribe for more updates as we continue highlighting the latest 510(k) approvals weekly!

✅ Weekly Regulatory Roundup

By Martin King, September 16, 2024

Click to view the Regulatory Roundup

In This Week's Regulatory Roundup

🔥 Updates from: 📌 𝘈𝘕𝘝𝘐𝘚𝘈 𝘉𝘳𝘢𝘻𝘪𝘭📌 𝘊𝘋𝘚𝘊𝘖 𝘐𝘯𝘥𝘪𝘢📌 𝘌𝘶𝘳𝘰𝘱𝘦𝘢𝘯 𝘊𝘰𝘮𝘮𝘪𝘴𝘴𝘪𝘰𝘯📌 𝘌𝘶𝘳𝘰𝘱𝘦𝘢𝘯 𝘔𝘦𝘥𝘪𝘤𝘪𝘯𝘦𝘴 𝘈𝘨𝘦𝘯𝘤𝘺📌 𝘐𝘚𝘖 (𝘐𝘯𝘵𝘦𝘳𝘯𝘢𝘵𝘪𝘰𝘯𝘢𝘭 𝘖𝘳𝘨𝘢𝘯𝘪𝘻𝘢𝘵𝘪𝘰𝘯 𝘧𝘰𝘳 𝘚𝘵𝘢𝘯𝘥𝘢𝘳𝘥𝘪𝘻𝘢𝘵𝘪𝘰𝘯)📌 𝘐𝘯𝘵𝘦𝘳𝘯𝘢𝘵𝘪𝘰𝘯𝘢𝘭 𝘔𝘦𝘥𝘪𝘤𝘢𝘭 𝘋𝘦𝘷𝘪𝘤𝘦 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘴 𝘍𝘰𝘳𝘶𝘮📌 𝘔𝘦𝘥𝘪𝘤𝘪𝘯𝘦𝘴 𝘢𝘯𝘥 𝘏𝘦𝘢𝘭𝘵𝘩𝘤𝘢𝘳𝘦 𝘱𝘳𝘰𝘥𝘶𝘤𝘵𝘴 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘈𝘨𝘦𝘯𝘤𝘺📌 𝘚𝘰𝘶𝘵𝘩 𝘈𝘧𝘳𝘪𝘤𝘢𝘯 𝘏𝘦𝘢𝘭𝘵𝘩 𝘗𝘳𝘰𝘥𝘶𝘤𝘵𝘴 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘈𝘶𝘵𝘩𝘰𝘳𝘪𝘵𝘺📌 𝘛𝘦𝘢𝘮 𝘕𝘰𝘵𝘪𝘧𝘪𝘦𝘥 𝘉𝘰𝘥𝘺, 𝘌𝘶𝘳𝘰𝘱𝘦📌 𝘚𝘸𝘪𝘴𝘴𝘮𝘦𝘥𝘪𝘤📌 𝘜𝘚𝘈 𝘍𝘰𝘰𝘥 & 𝘋𝘳𝘶𝘨 𝘈𝘥𝘮𝘪𝘯𝘪𝘴𝘵𝘳𝘢𝘵𝘪𝘰𝘯 𝘍𝘋𝘈📌 𝘞𝘰𝘳𝘭𝘥 𝘏𝘦𝘢𝘭𝘵𝘩 𝘖𝘳𝘨𝘢𝘯𝘪𝘴𝘢𝘵𝘪𝘰𝘯 𝘞𝘏𝘖

Plus, search Martin's new Index of Indexes!

Postscript 🐝

Time is running out to join our FREE courses!

1) "EUSTAR" Foundations of Medical Device Regulation (by Johner Institute)

2) MedTech Startup School: "Fundamentals of FDA Clearance and Compliance" (by lean RAQA)

- Sean 🐝

---

*Archived by Hermes*