Regulatory Focus™ > News Articles > Planned Poll Would Collect Information on Medical Devices for Emergency Database

Planned Poll Would Collect Information on Medical Devices for Emergency Database

Posted 07 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is planning to collect information on medical devices for their Emergency Shortages Data Collection System (ESDCS), according to a posting in the Federal Register 7 March.

FDA plans to communicate with regulatory officers at manufacturers who produce "key medical devices." FDA will make specific data requests during an initial call, and then follow up with addition calls and correspondence to confirm information or request additional details.

Key medical devices are devices "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."

"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," writes FDA.

The survey, dubbed the "Emergency Medical Device Shortages Program Survey" was originally developed after the terror attacks of 11 September 2001. The agency plans to survey manufacturers for information regularly, but not more frequently than every four months.


Read more:

Federal Register - Agency Information Collection Activities; Proposals, Submissions, and Approvals: Emergency Shortages Data Collection System


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