People In Brief
This article was originally published in The Gray Sheet
Executive Summary
Post-Gutman OIVD: Steve Gutman will leave FDA for academia at year-end after 17 years with the agency, including 14 years leading the device center's in vitro diagnostics oversight efforts. In 1993, Gutman took over the now-defunct clinical laboratory devices division in CDRH's Office of Device Evaluation. In 2002, he was the founding director of the Office of In Vitro Diagnostic Device Evaluation and Safety, which has jurisdiction over both pre-market and post-market activity for test kits. Product waivers under the Clinical Laboratory Improvement Amendments and regulation of analyte specific reagents were among hot-topic policy issues he addressed during his tenure. Moving forward policies on the oversight of genetic, genomic and pharmacogenomic tests has also been a major focus. Gutman's last working day at FDA will be Dec. 9. He will join the faculty at the University of Central Florida early next year and may also do some consulting, he says. Don St. Pierre, OIVD's associate director for policy and operations, will serve as acting director until a replacement is found