Type 8: Possible Combination Based on Cross Labeling of Separate Products

**Semantic type:** Manufactured Object

**Definition:** Investigational products that may meet the definition at 21 CFR 3.2(e)(3) or (4) but for which combination product status remains uncertain based on the information available at the stage of product development or evaluation, comprised of a separately marketed drug, device, and/or biological product.

**Synonyms:** - Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type) - Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)