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Compliance In Focus
Posted by Brandy Chittester on Thu, Nov 8, 2012

Medical Device Industry Impacted by Hurricane Sandy

Medical Device Industry Impacted by Hurricane SandySeeing those greatly effected by the recent storms is devastating. While in various places the assessment of damage is still being assessed, physically, FDA also is assessing the set-backs from the recent natural disaster. This was expressed in a recent FDA Voice Blog by Margaret Hamburg, M.D., FDA Commissioner.

The Commissioner notes that while many of us think of these major disasters in terms of property damage, FDA has a wider field of view.  “At FDA we also have to focus on the effects of natural disasters on the safety of the products we regulate and that consumers and patients depend on – everything from fresh produce to canned foods to medicines and high-tech medical devices.”

While the blog points out that FDA prepares early for any type of possible disaster, even with great preparation obstacles can occur. In fact, another recent article by RAPS, notes that many industry related functions are feeling the effects of Hurricane Sandy, including:

  • The Office of Personnel Management (OPM), the federal office charged with closing and opening government facilities, shut down FDA for two days as the storm bore down on the region
  • The closure of its offices for two days would not be without consequence for sponsors with target dates around those two days

This disruption will be felt more by those who submitted documents via paper submission in contrast to those who submitted to FDA electronically. Overall this could mean a costly delay for some sponsors.

However, it’s important to remember that FDA, industry, and public’s top priority in the realm of clinical research, medicine and innovative devices are the people who at the other end of these life-saving products. So, whether FDA ensures patient safety through the rigorous review of submissions- or by FDA inspecting facilities impacted by the storms, keeping people save remains the #1 goal.

Check out the FDA Voice Blog and share your thoughts on FDA’s preparation and response during this time.

Photo Credit: NASA Goddard Photo and Video

Topics: Hurricane Sandy, Margaret Hamburg, FDA, Medical Device Industry


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