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Alberto Gutierrez

Director

Alberto Gutierrez, Ph.D., is the director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health. He joined the FDA in 1992 as a researcher and a reviewer of purity and structure of vaccine components. He served as director of FDA’s division of chemistry and toxicology devices in 2005. Gutierrez also writes for the FDA’s blog, FDA Voice. Gutierrez received a bachelor’s degree from Haverford College and master’s and doctorate degrees in chemistry from Princeton University.

 

Wed, 04/25/2012 - 12:38
FDA Introduces Triage Pilot ProgramIncreasing efficiencies for device review
Wed, 04/25/2012 - 12:38
During the next few months, manufacturers of certain in vitro diagnostic and radiology products may start to notice they are getting decisions on their premarket notification submissions, aka 510(k), sooner than expected. This will be due to a six-…
      

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