TL09: Combination Products as Medical Tests
*Bipasa Biswas, FDA 

Keywords: Combination Products, Medical Tests, Drugs, Imaging

Medical diagnostic devices sometimes involve combination of two different components like for example a drug and an imaging device to measure the activity of the drug with the intention to detect via imaging a specific pathology in an anatomical location. Such devices typically involve injecting the drug and require an imaging device to locate the region of absorption of the drug at a specific anatomical region. Such devices are packaged as combination products which require joint review by two different centers within FDA. Such studies often involve dose finding for the drug and pre-clinical studies to evaluate the safety of the drug. As for clinical validation the device is evaluated for its performance by its ability to detect the particular condition of interest. Challenges and experiences with such devices will be the topic of this roundtable and I look forward to each member sharing their experience with such combination products.