Expanding on what Aasutosh said above, the primary mode of action (PMOA) is a significant process because it determines the regulatory and product development framework. A PMOA is determined by asking these 2 questions, “what is the device’s MOA?” and “what is the drug’s MOA?”. So if it is determined from the PMOA that a drug is involved than an abbreviated new drug application (ANDA) is required. This is submitted to the FDA for review and the potential approval of the drug. The biologic license application (BLA) is required to be submitted to the FDA if it involves a biologic product. Requirements of the BLA is application information, product/manufacturing information/preclinical studies, clinical studies and labeling. If a device is involved than premarket notification (“510(k)) is necessary. This is done if a Premarket Approval application (PMA) is not required.