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Wednesday, December 19, 2012
FDA Approval Process for Medical Devices
The U.S. Food and Drug Administration (FDA) must approve any medical device before it may be released for public use, but every medical device comes with the potential for complications. And even with the FDA’s scrutiny, thousands of innocent consumers suffer severe personal injuries and wrongful death each year due to defective medical devices.
If you were hurt or a loved one died due to a defective medical product, the nationwide network of experienced attorneys at The Cochran Firm may be able to help you seek the justice you deserve and financial compensation you need to cope with medical expenses, lost income, pain and suffering, and other damages.
The list of products the FDA considers medical devices ranges from simple objects such as tongue depressors to complex surgical implements such as hip implants. The FDA defines a medical device in part as an instrument that is:
• “Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them…”
• “Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease…”
• “Intended to affect the structure or any function of the body … and which does not achieve any of its primary intended purposes through chemical action within or on the body … and which is not dependent on being metabolized for the achievement of any of its primary intended purposes.”
In addition to meeting these requirements, manufacturers of medical devices must conduct biocompatibility testing and clinical trials, and submit premarket data to the FDA. There are different classes of medical devices, and each must meet varying requirements during the FDA’s regulatory review.
If you suffered injury or a family member was killed as a result of a defective medical device, please contact The Cochran Firm for a free case evaluation and to locate an experienced injury attorney near you.
If you were hurt or a loved one died due to a defective medical product, the nationwide network of experienced attorneys at The Cochran Firm may be able to help you seek the justice you deserve and financial compensation you need to cope with medical expenses, lost income, pain and suffering, and other damages.
The list of products the FDA considers medical devices ranges from simple objects such as tongue depressors to complex surgical implements such as hip implants. The FDA defines a medical device in part as an instrument that is:
• “Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them…”
• “Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease…”
• “Intended to affect the structure or any function of the body … and which does not achieve any of its primary intended purposes through chemical action within or on the body … and which is not dependent on being metabolized for the achievement of any of its primary intended purposes.”
In addition to meeting these requirements, manufacturers of medical devices must conduct biocompatibility testing and clinical trials, and submit premarket data to the FDA. There are different classes of medical devices, and each must meet varying requirements during the FDA’s regulatory review.
If you suffered injury or a family member was killed as a result of a defective medical device, please contact The Cochran Firm for a free case evaluation and to locate an experienced injury attorney near you.
posted by Admin at 8:33 AM
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