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Medical Devices: Approval Process and Responsibility

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1. What is the approval process to bring a medical device to market in the US?
2. Who should be held responsible for detrimental health effects related to that medical device or product? ....What if the device or product were being used in an "off-label" manner, or not in accordance with manufacturer's directions?

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Solution Summary

This solution explains the approval process to bring a medical device to the market in the U.S., who should be held responsible for detrimental health effects from medical device products, and related issues. A thorough discussion is provided. Includes 3 references.

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1 -- There is generally a five-step process to gain FDA approval for a medical device in the U.S. market. After the medical device has been developed and manufactured, it goes through a more thorough engineering development process. This takes place at the expense of the manufacturing company. It is a process where the device goes through intense analysis and testing to determine if the device essentially holds up to the manufacturer's claims, or if further revision is necessary. Once the device is ready for the market, the device undergoes clinical trials. This is a highly regulated process and has strict oversight to ensure that the participants in the clinical studies are treated with the utmost of care and safety at all times, while testing the device.

The trial period can have one of three outcomes. The device ...

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