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USA's RWD Shift: Pure Global on The New Evidence Backdoor
In the final days of 2025, the US FDA made a pivotal change to how it evaluates medical devices, opening the door for Real-World Data (RWD) to take center stage in regulatory submissions. This episode breaks down what this policy shift means for the MedTech industry, moving beyond the traditional reliance on expensive clinical trials.
We explore the immense opportunities this creates for faster, more cost-effective market access, especially for devices already approved outside the United States. We also uncover the significant challenges that come with this new frontier, from data integrity and patient privacy to the complex task of harmonizing global data sources into a submission-ready format for the FDA.
**Case Study:** Imagine getting FDA clearance for your device without a new, multi-million dollar US trial. A new FDA policy on Real-World Data might just be the key, but using it is complex and filled with pitfalls.
**Key Takeaways From This Episode:**
* What exactly did the FDA change about using Real-World Data?
* Which device classes will benefit most from this new guidance?
* How can data from international markets now support a US submission?
* What are the biggest mistakes companies make when compiling RWD for regulators?
* Is your existing post-market data good enough for a pre-market submission?
* How can AI tools help validate and structure RWD for the FDA?
* What are the key privacy pitfalls to avoid when using patient data?
Contact us at [email protected], visit https://pureglobal.com/, or explore our FREE AI tools and medical device database at https://pureglobal.ai/.
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By Ran ChenIn the final days of 2025, the US FDA made a pivotal change to how it evaluates medical devices, opening the door for Real-World Data (RWD) to take center stage in regulatory submissions. This episode breaks down what this policy shift means for the MedTech industry, moving beyond the traditional reliance on expensive clinical trials.
We explore the immense opportunities this creates for faster, more cost-effective market access, especially for devices already approved outside the United States. We also uncover the significant challenges that come with this new frontier, from data integrity and patient privacy to the complex task of harmonizing global data sources into a submission-ready format for the FDA.
**Case Study:** Imagine getting FDA clearance for your device without a new, multi-million dollar US trial. A new FDA policy on Real-World Data might just be the key, but using it is complex and filled with pitfalls.
**Key Takeaways From This Episode:**
* What exactly did the FDA change about using Real-World Data?
* Which device classes will benefit most from this new guidance?
* How can data from international markets now support a US submission?
* What are the biggest mistakes companies make when compiling RWD for regulators?
* Is your existing post-market data good enough for a pre-market submission?
* How can AI tools help validate and structure RWD for the FDA?
* What are the key privacy pitfalls to avoid when using patient data?
Contact us at [email protected], visit https://pureglobal.com/, or explore our FREE AI tools and medical device database at https://pureglobal.ai/.