How to Conduct a Regulatory Pathway Assessment Series: FDA 103: Earning Extra “FDA Credits”

This course covers pivotal technological aspects, claims, and indications influencing regulatory strategies. Gain insights into essential regulatory tools like pre-submission, 513(G), breakthrough, and SteP. By understanding these tools and considerations, you'll be better equipped to navigate and determine the optimal regulatory pathway for specific products and technologies.

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:

Grasp the core technological aspects, claims, and indications that impact regulatory pathways and strategies.
Recognize and comprehend the significance of tools like pre-submission, 513(G), breakthrough, and SteP in the regulatory context.
Analyze how specific considerations can influence and shape the decision on a regulatory pathway.
Integrate understanding of tools and considerations to determine the best regulatory approach for specific products or technologies.