Many medical devices are essential products to the patients who use them. If the supply of these devices were interrupted—in the case of a natural disaster such as a hurricane or earth quake, for example—lives would be at stake.
To prevent such scenarios from becoming reality, FDA created the Emergency Medical Device Shortages Program Survey. Developed after the September 11, 2001, terrorist attacks, the survey is intended to allow FDA to collect data on domestic inventory, manufacturing capabilities, distribution plans, and raw material constraints for medical devices that would be in high demand or vulnerable to shortages if a disaster or emergency would strike or certain regulatory actions were taken.
Now known as the Emergency Shortages Data Collection System, the electronic database is accessible only to members of the CDRH Emergency Shortage Team and senior managment. Updates are made to the system no more frequently than every four months.
FDA is currently allowing public comments on the Emergency Shortages Data Collection System, specifically addressing the following:
The comment period closes May 7, 2012.