Q & A: FDA Medical Device Investigator Offers Insights on Inspection

For this article, MasterControl Inc., a leading software provider for life sciences and other regulated industries, interviews Lori A. Carr, a medical device specialist with the FDA’s Office of Regulatory Affairs (ORA) in the Denver District Office. ORA is the lead office for all of FDA’s field activities. Investigators (also called consumer safety officers) like Carr are on the front line of safeguarding public health, conducting about 22,000 inspections of domestic and foreign manufacturers a year.