Training Program Title
Clinical Research- Device Development 101
CTSA Hub Administered
Training Program Description
This short course provides an introduction to device development pathways and regulations.
Device, IDE (Investigational Device Exemption)
Digital Commons Disciplines
Cost to Access
Medicines Development and Regulation
- Analyze the medical device regulatory pathways in the United States
- Differentiate between Class I, II, and III devices
- Describe combination drug-device products
Principal Investigators; Clinical Research Professionals (other than PI); Undergraduate, graduate or professional degree students; Post-doctoral scholars
Approximately 3-6 hours should be spent on reviewing the introductory materials, including embedded FDA lectures and articles. Following engagement with the course materials, a brief self check quiz is provided.