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Medical devices improve patients’ health and well-being in a variety of ways. Most of the time, these devices function as designed and intended.
At the end of the day, however, medical devices are designed and manufactured by people, which means they are not exempt from possible defects.
Below, our Los Angeles product liability attorneys discuss the process by which a defective medical device is identified and removed from the market.
FDA Recall Process
The Food and Drug Administration (FDA) is responsible for monitoring and regulating products intended for use in or on the human body, including food, medicine, medical devices, and more.
As such, the FDA is in charge of identifying, removing, or correcting products that are in violation of their guidelines.
Depending on the nature of the device defect, the removal process may include one of the following measures:
Correction: This involves the repair or modification of a device without its physical removal to another location.
Market withdrawal: This involves the manufacturer’s removal or correction of a device which involves a minor violation that would not be subject to legal action by the FDA.
Recall: This involves the manufacturer’s removal or correction of a device that the FDA considers to be in violation of its guidelines.
Removal: This involves the physical removal of a device from its point of use to some other location for repair or modification.
Risk to health: This means that there is a reasonable probability that use of the device will cause serious adverse health consequences or death.
Harmed by a Defective Medical Device? We’re Here to Help
At Shoop | A Professional Law Corporation, we know the physical, emotional, and financial turmoil that a defective medical device can have on a patient. As such, we make it our mission to stand up for patients’ rights against the interests of large manufacturers and insurance companies.
If you or someone you love has been harmed by a defective medical device, we encourage you to contact us today at (866) 884-1717 to schedule a free case evaluation.