Top 3 Mistakes to Avoid in your FDA 510(k) Submission

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.

AGENDA

• 11:30 a.m. Speaker Panel + Q&A
• 1:30 p.m. Networking

CO-SPONSORS

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. 

RECERTIFICATION CREDITS

RAC holders may claim two recertification credits for attending.

REGISTRATION
Registration is accepted through April 12.
$35 member | $45 nonmember | $25 student 
Student Discount Code: VIR8284BH