arcoro Glossar

Food and Drug Administration (FDA)

The US Food and Drug Administration is responsible for the approval and continuous control of food, food and pharmaceuticals. Medical devices are subdivided into three FDA classes with reference to the potential risk for patients and users. Medical device manufacturers who want to bring their products into circulation in the American market must implement an FDA-compliant quality management system in order to comply with American standards and guidelines. The requirements here are similar to those of the European ISO 13485, but the ISO13485 certificate is not recognized by the FDA.

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Sven J. Kolthof



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