The Food and Drug Administration has issued new final guidance for manufacturers of “custom devices.” These devices do not have to comply with the same regulatory requirements for most medical devices because they are made for patients with rare medical conditions or to meet the special needs of physicians.
Two years ago, the Food, Drug and Cosmetics Act was amended to introduce new procedures regarding custom devices. For example, the amendments clarified that custom devices must include no more than “five units per year of a particular device type.”
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