How to Conduct a Regulatory Pathway Assessment Series

For those introducing new products without a clear regulatory blueprint, this series provides essential guidance, ensuring a smooth transition from concept to market-ready product.

This online course series offers a step-by-step guide through the fundamental five steps for product market entry. The curriculum highlights effective utilization of the FDA's databases to craft appropriate product clearance or approval pathways. Lessons also delve into submitting the necessary information to the FDA, emphasizing key considerations. For those introducing new products without a clear regulatory blueprint, this series provides essential guidance, ensuring a smooth transition from concept to market-ready product.

Learning Level: Basic
Total Length: 3 Hours
RAC Credits: 3
Enrollment Period: 12 months

Products included in this bundle:

Lesson 1: FDA Organization and CDRH Role

Lesson 2: FDA Risk-based Medical Device Classification

Lesson 3: Five Steps to Market

1-2 Hours | 1 RAC

Credits

Lesson 1: Introduction

Lesson 2: FDA Product Classification Database

Lesson 3: FDA Device Establishment Registration and Listing Database

Lesson 4: FDA 510(k) Database

Lesson 5: FDA De Novo Database

Lesson 6: PMA Database