Case Studies

Pharmaceutical/Drug
A fictional case study, generated by the FDA, of how a small pharmaceutical company brings a drug to market.

Medical Device
Case studies that cover the steps of the medical device approval process including regulatory pathways, risk management, premarket approval, premarket notification, de novo medical devices, and investigational device exemption.

Medical Technology/mHealth
Does your medical technology/mHealth need FDA approval

FDA classification of medical technology/mHealth
Classify your medical device

FDA guidance for mobile medical health applications
Mobile medical applications: Guidance for Industry and Food & Drug Administration Staff