Fundamentals of the 510(k) Premarket Notification Process

August 14, 2026

9:30 am - 1:00 pm

Front Range Community College, Westminster, CO

Course Introduction

This course provides an overview of the U.S. FDA 510(k) Premarket Notification process, the most common regulatory pathway used to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device. Participants will gain a practical understanding of regulatory requirements, submission components, performance testing expectations, and strategies for preparing a successful 510(k) submission using the eSTAR system. The course is designed for regulatory affairs professionals, quality professionals, product developers, engineers, and project managers involved in medical device development and commercialization.

Learning Objectives

By the end of this course, participants will be able to:

1) Explain the FDA 510(k) Regulatory Framework

· Describe the purpose of the 510(k) process, device classifications, and the concept of substantial equivalence.

2) Identify Required Elements of a 510(k) Submission

· Recognize key submission components, including device descriptions, intended use statements, labeling, and supporting documentation.

3) Evaluate Testing and Evidence Requirements

· Determine appropriate performance including, biocompatibility, software, electrical safety, and clinical testing requirements based on device risk and characteristics.

4) Develop a 510(k) Strategy

· Select suitable predicate devices, assess regulatory risks, and create a submission plan that supports timely FDA review and clearance.

5) Have familiarity with the FDA 510(k) eSTAR template and submission process.