Based on the number of requests from manufacturers addressed to the Agency concerning the classification of their products as a drug or a device, the FDA published a new guidance which should help them classify their products. Even the distinction between combination products and biological products is made in the document too.
Substances can be defined as drugs when used for diagnosis, cure and prevention of disease and when they affect the structure or any function of the body of man or animals. Devices, on the contrary, define products used for diagnosis, cure and prevention which do not achieve their primary intended purpose through chemical action within the body and are not dependent upon being metabolized in the body. If a product meets both definitions, the Agency generally classifies it as a device. Biological products (e.g. virus, serum, blood, blood component, protein (not chemically synthesized), antitoxin) which also meet the drug and devices definitions are generally classified as biological products.
If the classification of a product is unclear, a Request for Designation (RFD) can be submitted to the FDA Office of Combination Product. The Agency should give an answer within 60 days. Referring to the classification of similar products can be helpful to find out the classification of a product. However, the FDA prefers a case-by-case decision based on the specific characteristics of the product.
Please also see the Draft Document for further information.
Dr Robert Eicher
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)