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FDA Guidance Document Clarifies When Product Changes Establish Need for Recall

December 16, 2014  ·  By HM&M

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The FDA has instituted a final guidance document in order for companies to clearly distinguish a recall from a market withdrawal. Part of the draft version of the new guidance called for reporting of any enhancement of a product, a factor critical when determining potential health risks and dangers to consumers.

Many in the medical device industry were concerned about additional paperwork rather than focusing on the importance of detailed documentation for the benefits of safety. Certain devices have been approved for market that have represented an upgrade, innovation, or correction to a previous device and have resulted in recalls.

It is a manufacturer’s responsibility to find the original source of the problem and not look at a defect as an isolated incident. One of the main intentions of the new guidance is to clarify when a change to a device constitutes a product recall. One example states, “a change to a marketed device to address false or misleading labeling or other labeling violations would generally constitute a medical device recall.”

The FDA categorizes recalls into the following groups:

  • Class I recall;
  • Class II recall;
  • Class III recall;
  • Market withdrawal; and
  • Medical device safety alert.

A Class I recall is a situation where there is reasonable probability that exposure of a defective product will lead to serious adverse health conditions or death. A market withdrawal is when a product has a minor violation that is removed from market or corrected. All products or enhancements to products must abide by FDA regulations and the FD&C (Food, Drug, and Cosmetic Act).

Our law firm is here to navigate the specifics of regulations and laws set forth to protect consumers in these situations. When it comes to your health and safety, proper protocol is crucial. We have a team of investigators and dedicate our practice to fighting cases involving helping people who have suffered personal injuries due to defective devices.

If you have been injured as a result of a defective product in Illinois, it is your right to seek accountability from the manufacturing company responsible. Contact an experienced product liability attorney in Chicago. Call the law office of Hurley McKenna & Mertz, P.C. at 312-553-4900 for a free case consultation.”

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