To help monitor OIVD
's efforts on these matters, AdvaMed recently brought in a staffer, Khatereh Calleja, as the new associate VP for technology and regulatory affairs to focus exclusively on regulatory efforts in the diagnostics sector.
The Food and Drug Administration (FDA) update, given by Alberto Gutierrez, PhD, officer for In Vitro Diagnostic Device (OIVD
) Evaluation and Safety, provided updates on organizational changes, FDA guidances, user fees, and pre-/post-market areas.
April 22-25 35th Annual Meeting & OIVD
510(k) Workshop, Association of Medical Diagnostics Manufacturers, Marriott Bethesda North Hotel and Conference Center, Bethesda, MD.
Alberto Gutierrez, formerly director of the OIVD
Division of Chemistry and Toxicology Devices, will replace St.