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The FDA 510(k) process says that a device can be approved for use if it is deemed to be substantially equivalent to a legally marketed
The FDA 510(k) process says that a device can be approved for use if it is deemed to be substantially equivalent to a legally marketed device. If you worked for a company that had to evaluate a new material for 510(k) approval identify four characteristics that you would consider important to determine whether two biomaterials are substantially aquivalent.
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