X-Ray Opacifying Preparations & Diagnostic Reagents

Iodinated contrast agents are regulated by FDA as drugs under the Center for Drug Evaluation and Research (CDER), requiring an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) for marketing in the US. This means foreign manufacturers must have an approved application and be subject to drug GMP inspections — a different standard than applies to IVD device reagents under the same SITC heading.

FDA classifies IVD reagents by risk level. Class I reagents (low risk, general controls only) are often exempt from 510(k) requirements, while Class II reagents require 510(k) clearance demonstrating substantial equivalence to a predicate device. Class III reagents — those used in high-stakes clinical decisions — require full PMA. Importers should verify the FDA classification of each specific reagent before assuming it is exempt from premarket submission.