Overview:

• Title: the FDA 3P510K Guidance for Third Party Review
• Date: Tuesday, January 26, 2021
• Time: 10:00 AM Eastern Standard Time
• Duration: 1 hour

Introduction

During this webinar, we will introduce the FDA's new guidance 3P501K, for third party review. Throughout the session we will walk our viewers through the process and showcase SGS's capabilities to support medical device manufacturers.

Objectives

• To describe the third party 510K process to manufacturers.
• Describe the process of the third party 510K review.
• Describe SGS capabilities under the program.
• Describe SGS's end to end training, certification, testing and product services capabilities.

Agenda

• Welcome and Inform
• Define the 3P510K process
• Define SGS involvement in the 3P510K process
• SGS end to end assessment capabilities
• Questions

Background

One of the better ways to get a medical device to market is a 510K application. A 510K is an application to the US FDA claiming that a device a manufacturer intends to place on the market in the US is substantially equivalent to a currently marketed device in the US. The US FDA has instituted a program by which designated companies can review certain moderate to low risk products and provide a recommendation to the FDA to allow the 510K to be issued. The reason for the program is to speed devices to market by providing quicker turn around for 510K reviews.