Alongside the evaluation of a material’s suitability for contact with food, FDA compliance is frequently also used in the field of medical technology to provide users with important information on risk assessment. However, it is not a binding requirement for the use of materials in the medical or pharmaceutical field. The American Food and Drug Administration (FDA) assesses the suitability of materials for direct and indirect contact with food. Raw materials, additives and properties of plastics are specified by the FDA in the “Code of Federal Regulations” CFR 21. Materials that meet the relevant requirements are regarded as FDA compliant.
A FDA-compliant formulation is valid without time limitation, as long as the raw materials are not changed. For this reason, only the manufacturer of a product may issue this FDA certificate, as only he/she knows the formulation and can guarantee that FDA-compliant raw materials are used. As raw materials for use in the medical sector mostly comply with the requirements of the FDA, this can be certified accordingly on an order-by-order basis in order to guarantee seamless traceability.