Top 3 Mistakes to Avoid in your FDA 510(k) Submission
Apr 12, 2023
11:30 a.m. to 2:30 p.m.
3175 Bowers Avenue, Santa Clara, CA 95054
/Event Type: hybrid
Cost: $35 member | $45 nonmember | $25 student (Student Discount Code: VIR8284BH)
Through the lens of the FDA
Join expert FDA medical device reviewers and industry professionals in an interactive discussion about the regulatory process and learn how to:
- Meet administrative requirements and avoid FDA administrative holds and RTA letters.
- Avoid AINN holds holds on medical devices by ensuring performance testing can adequately support a substantially equivalent (SE) decision.
- Get 510(k) products cleared by the FDA faster by using the FDA’s third-party program whenever possible.
The panel includes renowned industry professionals who specialize in software as medical devices, regulatory affairs, quality assurance, and clinical strategy as well as a reviewer from the FDA’s 510(k) Third-Party Review Program.
If you attend in person, this is also a chance to meet up with your colleagues and peers in the regulatory affairs community, meet instructors from the UCSC Silicon Valley Extension Regulatory Affairs certificate program, and enjoy a bite to eat.
- 11:30 a.m. Speaker Panel + Q&A
- 1:30 p.m. Networking
The Medical Device Quality and Design and Regulatory Affairs certificate programs at UCSC Silicon Valley Extension and the RAPS San Francisco Bay Area chapter are sponsoring this knowledge-sharing and community-development event.
RAC holders may claim two recertification credits for attending.
Registration is accepted through April 12.
$35 member | $45 nonmember | $25 student
Student Discount Code: VIR8284BH