This short course will provide an overview of device, drug, and combination product regulations with a focus on the application of the existing scheme to digital health products. The course will also cover recent policy developments that have been implemented to assess whether a digital health product is considered a medical device as well as when a premarket application is needed. The course will discuss considerations for combining mobile apps/software with a drug or biologic product to understand the holistic regulatory environment that should be considered for digital health products.
At the conclusion of this short course, participants should be able to:
- Recognize how the current digital health regulatory framework interfaces with existing medical device and drug laws and regulations
- Apply the CDRH Guidance Documents/policies to assess whether a digital health product meets the definition of a device
- Identify when a digital health product would be considered promotional labeling or required labeling for a drug or biologic application