Documents CBER 510(k) Challenges and Strategies Susan Finneran Director of Clinical and Regulatory Affairs.

Slide 1 CBER 510(k) Challenges and Strategies Susan Finneran Director of Clinical and Regulatory Affairs Slide 2 Copyright © 2009 Haemonetics Corp.2 Background on Haemonetics…

Documents CBER CBER 510(k) Issues Sheryl A. Kochman, MT(ASCP) Chief, Devices Review Branch DBA/OBRR/CBER IVD.....

Slide 1 CBER CBER 510(k) Issues Sheryl A. Kochman, MT(ASCP) Chief, Devices Review Branch DBA/OBRR/CBER IVD Roundtable – OIVD Workshop April 23, 2003 Slide 2 CBER Why does…