The Food and Drug Administration, HHS request for comments on effects of extreme weather on medical device safety and quality.

The Food and Drug Administration (FDA) is studying the potential effects of extreme weather and natural disasters on medical device safety and quality. FDA is announcing at this time its request for comments on the topic of extreme weather effects on medical device safety and quality.  Submit either electronic or written comments by May 10, 2013.  Submit electronic comments to http:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document.

FDA is seeking information particularly on the following questions; however, you may respond to any, all, or none of these questions, or you may submit comments on any topic relating to the purposes of this document, regardless of whether a topic is addressed by these questions:

  1. Have you experienced any of the scenarios or any other effects of EW on the safety and effectiveness of medical devices?
  2. How did you respond to extended periods of electrical or network outages or other events related to EW?
  3. In past EW situations, how was communication handled between the manufacturer facility and patients/users about the safe use of products during EW events? How did you provide/ receive information about device failures? Do you have any suggestions for complaint handling during these situations?
  4. How should industry optimize the design, production, and use of medical devices during and after EW events?
  5. How could products be monitored during transport and storage in light of potential interruptions and environmental extremes from EW events?
  6. How can manufacturers best prevent or minimize temporary shortages of medical devices when EW may damage existing inventory or impact just-in-time production of critical components?
  7. In what ways have EW events impacted your manufacturing site? What were the lessons learned during the recovery process as you returned to production? What changes were made as a result of the EW event?
  8. Are there additional steps FDA can take to help industry anticipate, mitigate, or better tolerate the effects of EW?
  9. Are there steps that standards development or other professional organizations can take to support industry to optimally prepare for EW events?

FOR FURTHER INFORMATION CONTACT: Jennifer Kelly, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3429, Silver Spring, MD 20993–0002, This email address is being protected from spambots. You need JavaScript enabled to view it.  (more)

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