What is the role of the FDA in medical device injury claims?

The role of the Food and Drug Administration (FDA) in medical device injury claims is to protect the public safety. The FDA is responsible for reviewing and approving medical devices before they can be sold and used in the United States. Once a device is approved, it may be tracked for safety and effectiveness through a post-marketing surveillance program. The FDA can recall or limit the use of a medical device if they find it to be unsafe or ineffective. The FDA is also responsible for collecting reports of device-related injuries and accidents through the Manufacturer and User Facility Device Experience (MAUDE) database. This information helps the FDA identify safety issues with devices and take appropriate action. The FDA does not directly award compensation to people who are injured by medical devices, but their reports can be used to help support medical device injury claims. If a medical device is found to be unsafe, injured people may be entitled to compensation from the device manufacturer or from the company they bought the device from. In South Dakota, individuals can seek compensation through medical device injury claims in civil court.

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What is the role of the FDA in medical device injury claims?

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