FDA's eSTAR template has transformed the 510(k) submission process, but success still depends on developing a strong regulatory strategy and presenting a complete, well-supported submission.
Join Nancy Sauer, Owner and President of Nancy Sauer Regulatory Consulting llc, for an interactive session focused on practical approaches to preparing effective 510(k) submissions. Drawing on extensive experience supporting medical device manufacturers across a wide range of technologies, Nancy will share insights on planning a submission strategy, leveraging the eSTAR template efficiently, avoiding common mistakes, and navigating interactions with FDA throughout the review process.
Topics will include:
- Best practices for developing a successful 510(k) evidence strategy
How to write a compelling substantial equivalence section
- Effective use of FDA's eSTAR template
- Lessons learned from FDA reviews and interactions
- Practical tips for improving submission quality and review efficiency
Whether you are preparing your first 510(k) or looking to refine your current approach, this session will provide actionable insights to help streamline your regulatory pathway and improve submission outcomes.
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speaker
Nancy Sauer
