The Evolving Regulatory Landscape for Medical Device Servicers
FDA is required to deliver a report to Congress in mid-2018 that will include a recommendation on oversight for reusable medical device service organizations. On the surface, this could encompass not only OEM and independent service companies, but also clinical engineering operations. There are multiple efforts underway by various industry groups to prepare recommendations for FDA and to establish governance policy for servicing activity. This session will briefly review the history of oversight for service organizations and activities and then provide an update on FDA and non-governmental efforts to establish oversight guidance for service activities.