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

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

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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