How to Conduct a Regulatory Pathway Assessment Series: FDA 102: Building a regulatory strategy from the ground up

Description

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

• 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

• 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