Webinar: Overview of the 510k Program and Tips to a Successful Submission
April 11 @ 12:00 pm - 1:00 pm
ONLINE EVENT APRIL 11 @ 12:00 PM – 1:00 PM PDT
Navigating the FDA’s 510(k) program for marketing medical devices can be complex and challenging. In this session, you will be provided a comprehensive understanding of the 510(k) program, the principle of substantial equivalence, as well as guidance for those who are modifying their already 510(k) cleared devices or submitting a new 510(k) Notice. By the end of the session, you will be equipped with the knowledge and best practices to ensure a smooth and successful 510(k) submission process and identify best practices for documenting modifications internally.
Date: April 11th
Time: 12:00 noon-1:00pm PT
Registration: free for member / $15 for nonmember
About the Speaker:
Director of Regulatory Policy, International, and Global Harmonization
Former FDA 510(K) Program manager
As part of Medtronic’s global regulatory policy team in Washington, DC, Fatemeh Razjouyan is actively shaping the global regulatory landscape to promote harmonization. She represents Medtronic in industry working groups and coalitions to advance its goal of providing patients with safe and innovative therapies. Fatemeh was previously the head of US regulatory policy in BD. Prior to that, she held various roles in the Center for Devices and Radiologic Health (CDRH) at the US Food and Drug Administration (DSA). From 2013 to 2018, she led the 510(k) review program in the office of In Vitro Diagnostics and Radiological Health (OIR) in CDRH, where she trained review staff, drafted guidance documents and work instructions, and assisted in the implementation of the Medical Device User Fee Amendments (MDUFA) and regulatory policy for the 510(k) program. during her tenure at OIR, Fatemeh was the public face of OIR on several FDA policy issues, including OIR 510(k) review practices. She received multiple awards during her tenure at the FDA.
Fatemeh holds a bachelor’s degree in biomedical engineering and a master’s degree in electrical engineering from the George Washington University.
Fawn Zhang, OCRA President Elect
Certificates of attendance will be emailed after the event.
Questions? For more information, please contact us at firstname.lastname@example.org
Randy George, President
Fawn Zhang, President-Elect
OCRA’s non-profit Federal Tax ID# 33-0630455
Registration should be made in the name to be used on the certificate of completion