Using Real-World Evidence in FDA Submissions: A Guide for Devicemakers
Have you figured out how to make real-world evidence (RWE) work for your marketing submissions? RWE is rich in both opportunities and challenges. And with the FDA strongly indicating it wants to see more RWE in applications, it is not only time to get comfortable with it, but proficient.
That’s where Using Real-World Evidence in FDA Submissions: A Guide for Devicemakers comes in. With it, you will understand and harness RWE appropriately — in all its forms and sources — to comply with the FDA’s push.
This report will prepare you for everything you must know and do to develop new products using RWE, including which kinds of RWE are best suited to demonstrating a device’s effectiveness and safety, how the agency wants RWE presented in premarket and postmarket submissions, and how the FDA’s thinking on the subject is continuing to evolve.
In short, Using Real-World Evidence in FDA Submissions will empower you to understand RWE and use it to your advantage.
The dissection of nine real-life examples of devicemakers that used RWE in their successful FDA submissions are key to what makes this volume essential, coupled with its clarification of the FDA’s 2017 guidance and policy statements, and explanation of the key criteria for effective RWE — relevance, reliability, accuracy.
- How to evaluate real-world data (RWD) to determine whether it is sufficient to generate the types of RWE that can be used to support regulatory decisionmaking for medical devices
- When RWE meets the criteria for valid scientific evidence
- Benefits of using medical device registries as a postmarket control
- How RWE can supplement or even replace data generated by traditional clinical trials
- Purposes for which RWD can be used
- General examples of how RWE can be used (e.g., expanded indications, postmarket surveillance, control groups, objective performance criteria)
- Challenges in using RWE
Success is steps away when you use RWE to strengthen your applications. Find your RWE roadmap in Using Real-World Evidence in FDA Submissions: A Guide for Devicemakers.
About the Contributor
Kristin Zielinski Duggan, partner at Hogan Lovells, has a wealth of experience with the entire FDA regulatory process and agency interactions: devising regulatory strategy for innovative products, supporting clients at presubmission meetings, assisting with preclinical and clinical programs and IDEs, preparing regulatory submissions and appealing agency decisions. Having prepared companies for dozens of advisory panel meetings over the years — including panel meetings to review 510(k) notices and PMAs, general issues panels and classification panels — Ms. Duggan is a top thought leader in this area. She has been involved with all of the meetings of the Medical Devices Dispute Resolution Panel (MDDRP) to date.
Who Will Benefit
- Regulatory staff
- Clinical trial designers
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Kristin Zielinski Duggan
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