Gottlieb: 50 Critical Devices At Risk Of Shortage Due To Hurricanes, FDA Eyes Importation

Approximately 50 critical medical devices are being monitored for risk of shortage due to Hurricanes Irma and Maria, FDA Commissioner Scott Gottlieb said Friday (Oct. 20). In response, the agency is looking at allowing importation of these devices and allowing manufactures to shift production to alternative sites. FDA is working directly with about 10 manufacturers in Puerto Rico to prevent shortages of critical medical devices, some of which are sole-source. “To date, we’re monitoring about 50 types of medical devices...