FDA drops international device inspection pilot:
This article was originally published in Clinica
Executive Summary
After reviewing the results of a six-month pilot programme, the FDA has decided not to continue with a plan to have its district offices process routine international device establishment inspection reports. The programme results were inconclusive, the agency said, adding that new streamlined procedures by its Center for Devices and Radiological Health's Office of Compliance in Washington had resulted in "significant reductions" in both review times and in the time it takes to mail post-inspection letters to companies. This largely eliminated the need for the pilot programme, it said.