FDA plans med-tech shortage database
The FDA will begin collecting availability data on "key medical devices" for an Emergency Shortages Data Collection System, a survey originally planned after the attacks of Sept. 11, 2001.
Products in question are to include those "for which there will likely be high demand during a specific emergency/disaster, or for which there are sufficiently small numbers of manufacturers such that disruption of manufacture or loss of one or more of these manufacturers would create a shortage," and the FDA will survey device makers every 4 months at the most.
"Because of the dynamic nature of the medical device industry, particularly with respect to specific product lines, manufacturing capabilities, and raw material/subcomponent sourcing, it is necessary to update the data in the ESDCS at regular intervals," according to the federal watchdog agency. Read more
FDA closes nominations for IDE early feasibility pilot program
The FDA announced the end of the nomination period for the agency’s Early Feasibility Study Investigational Device Exemption pilot program. For already accepted sponsors the duration of the pilot program was extended to May 8, 2013. Read more