Regulatory Focus™ > News Articles > FDA Looks to Extend Medical Device-focused Emergency Planning System

FDA Looks to Extend Medical Device-focused Emergency Planning System

Posted 04 June 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is proposing to extend an information program known as the Emergency Shortages Data Collection System (ESDCS) through which it collects data on medical device shortages as part of a national counterterrorism and emergency preparedness strategy.

In a 4 June Federal Register posting, FDA explains ESDCS emanated from the events of 11 September 2001 and reflects its concerns that a shortage of particular medical devices could materially impact the federal government's ability to respond to disasters or emergencies.

Recognizing these concerns, FDA's Center for Devices and Radiological Health (CDRH) instituted the ESDCS to keep track of the domestic inventory of medical devices, the manufacturing capabilities of companies, the distribution plans for products, and the raw material needs and constraints of medical devices likely to be in high demand or vulnerable to shortages in emergency situations.

FDA concluded "such data could support prospective risk assessment, help inform risk mitigation strategies, and support real-time decision-making by the Department of  Health and Human Services during actual emergencies or emergency preparedness exercises."

Reflecting FDA's realization that information collected through ESDCS is potentially "commercially confidential," FDA has restricted access to the database to CDRH's emergency shortage team (EST) and other senior management on a need-to-know basis.

Data is obtained through a biennial telephone survey of medical device companies in which regulatory staff at the medical device company are contacted by CDRH and asked to supply data to the agency. FDA estimates the response will take approximately 90 minutes split up over the course of three successive conversations.

FDA estimates only 125 manufacturers will be contacted on the basis of their manufacture of devices likely to be in high demand during a specific emergency or due to their potential to disrupt supply chains and cause shortages.

Read more:

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

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