Weinstein was introduced at the meeting by CDRH director David Feigal, who hails from Minneapolis and toured several medical device facilities in the vicinity. Weinstein told the group that his office, recently established by Feigal, is designed to give focus to a variety of accessible dispute-resolution mechanisms, easing the way for industry to be heard. He said he will also provide an outreach to industry by speaking to trade associations. Weinstein invited industry members to use his services whenever they have problems with CDRH that they have been unable to resolve. The agency will also consider whether particular divisions within CDRH's ODE are devoting disproportionate staff time to presubmission discussions with accredited persons.
More details are available on the Web.
He also has held positions with the Public Health Service in New Orleans and the National Institutes of Health Clinical Center. He served his residency at the University of Copenhagen and was later the senior resident for clinical pathology at the University of Minnesota Hospitals. Meanwhile, his predecessor, Susan Alpert, MD, is headed for industry. Alpert left CDRH late last year to provide leadership for President Clinton's Food Safety Initiative at FDA's Center for Food Safety and Applied Nutrition. In her new capacity at Bard, Alpert will manage the quality, regulatory, medical, clinical, and environmental affairs functions for the company.