- This event has passed.
What’s New in FDA 510(k) & eSTAR Best Practice
June 26 @ 12:00 pm - 1:00 pm
What’s New in FDA 510(k) & eSTAR Best Practice
Date: Wednesday, June 26, 2024
Time: 12 noon – 1pm PT
Audience: Medical device regulatory affairs professionals who are involved in the 510(k) submission process.
Platform: Zoom
The panel will provide an overview of the recent updates and changes in FDA 510(k) program and guide the participants through best practices for preparing a 510(k) submission in the eSTAR system and share useful tips through case scenarios.
Submit your questions after registration and have them answered at the event!
Learning Objectives:
- Understand the recent updates and changes in FDA 510(k) program
- Learn best practices for submitting 510(k) applications in the eSTAR system
Register now to secure your spot and empower your team for success!
About the Speakers:
Heather Rosecrans, F.R.A.P.S., EVP, Medical Devices & Combination Products at Eliquent Life Sciences
Heather boasts over 45 years of public health and medical device expertise. Formerly the Director of the 510(k) Premarket Notification Staff at the FDA CDRH, she spearheaded regulatory policy implementation and led key programs. Heather’s significant contributions include drafting guidance documents and regulations of the 510(k), training FDA staff and other stakeholders, and shaping pivotal legislation. Her unparalleled experience has established her as a foremost expert in FDA 510(k) processes. With a B.S. in biology from Pfeiffer College, Heather now leverages her knowledge to consult and facilitate innovative device entry into the U.S.
Samantha Eakes, MPH, VP, Regulatory Affairs at Eliquent Life Sciences
Samantha brings over seven years of FDA regulatory consulting experience. With a background in public health, policy, and nonprofits, she offers strategic insight into regulatory challenges. Her expertise spans various FDA submissions, including 510(k) Premarket Notifications and Emergency Use Authorizations. Samantha has published articles on medical device topics and previously contributed to policy and advocacy at Management Sciences for Health. She holds a B.A. in psychology and an M.P.H. from Boston University.
Free for Member
$20 for Nonmember
Registering for your team of 5+ participants? Please email programs@ocra-dg.org.
Thank you to our Sponsors!
