FDA Compliance

The "Food and Drug Administration" (FDA) is a US authority that issues approvals for agents, foodstuffs, cosmetics and pharmaceutical products. In addition, it generates recommendations for the use of materials in facilities in the foodstuffs and pharmaceutical industries. This supplementary task is administered because the individual components, materials and design details have significant influence on the qualitiy of the end product.

Technologies Details

An “FDA Approval” can only be issued for a product generated in the particular facility in question. For components and materials there is no FDA approval; these parts are “FDA listed” in terms of their innocuousness if in direct contact with the product.
The FDA directives are published as so-called “Codes of Federal Regulations” (CFR…). The 21 CFR 170-199 directives have a special significance, in particular with regard to material selction for sensor manufacturers. They contain a listing of specifiations for plastics. Thus, 21 CFR 177.2415, for example, contains the plastic PEEK that is often used in the food and pharmaceutical market sectors.