How to Conduct a Regulatory Pathway Assessment Series: FDA 101 Navigating the FDA for the first time
Introduction course to the regulatory world of medical devices. Overview of the FDA organization and importance of a well-defined regulatory strategy. This first course introduces FDA risk-based device classifications, FDA product codes, regulatory controls, and the five steps to market for a new medical device.
At a Glance
- Target Audience: This is course is designed for professionals new to medical device regulatory affairs.
- Learning Level: Basic
- Total Length of Course: 1 Hours
- RAC Credits: 1
- Enrollment Period: 12 months
Learning Objectives
Upon completion of this course, participants should be able to:
- Identify the organizational structure of the FDA and the role of the CHRD
- Describe the FDA medical device risked-based classification
- Explain the five major steps for getting a medical device to market
Lesson Titles
- Lesson 1: FDA Organization and CDRH Role
- Lesson 2: FDA Risk-based Medical Device Classification
- Lesson 3: Five Steps to Market
