News

FDA Accepts Public Comments on Emergency Shortages Data Collection System


Posted by Jamie Hartford on March 16, 2012

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:

  • Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility.
  • The accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
  • Ways to enhance the quality, utility, and clarity of the information to be collected.
  • Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

The comment period closes May 7, 2012.

Jamie Hartford is the associate editor of MD+DI. Follow her on Twitter at @readMED.


Tags:
Printer-friendly version
No votes yet

Login to post comments