How to Conduct a Regulatory Pathway Assessment Series: FDA 102: Building a regulatory strategy from the ground up
This course provides an introduction into the different FDA databases used to build your regulatory strategy. The course covers the different information to review when considering your path to market.
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:
- Demonstrate the ability to proficiently navigate the FDA medical device databases.
- Identify and select the appropriate FDA database based on the specific type of information sought.
- Apply knowledge and skills to efficiently access relevant information within FDA medical device databases
Lesson Titles
- Section 1: Introduction
- Section 2: FDA Product Classification Database
- Section 3: FDA Device Establishment Registration and Listing Database
- Section 4: FDA 510(k) Database
- Section 5: FDA De Novo Database
- Section 6: PMA Database
- Section 7: Case Study
