Training Program Title

Clinical Research- Device Development 101

CTSA Hub Administered

no

Training Program Description

This short course provides an introduction to device development pathways and regulations.

Competency Keywords

Device, IDE (Investigational Device Exemption)

Digital Commons Disciplines

Medical Education

Public

yes

Cost to Access

no

Competency Domains

Medicines Development and Regulation

Learning Objectives

  1. Analyze the medical device regulatory pathways in the United States
  2. Differentiate between Class I, II, and III devices
  3. Describe combination drug-device products

Delivery Method

Online

Target Learners

Principal Investigators; Clinical Research Professionals (other than PI); Undergraduate, graduate or professional degree students; Post-doctoral scholars

Learning Level

Fundamental

Onboarding

no

Frequency

On demand

Time Needed

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.

Associated Assessment

yes

Assessment Methods

Learning outcomes

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