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*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*

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.

Learning objectives

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