Rocky Mountain Regulatory Affairs Society

Events

2026

Fundamentals of the 510(k) Premarket Notification Process
Friday, August 14, 2026
College Hill Library, Front Range Community College, Westminster, Colorado
9:30 am - 1:00 pm

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.

SPEAKER:

Daniel Simpson, Director of Regulatory Affairs, DCN Diagnostics

REGISTRATION FEE
The individual fee for the 510(k) course is $395.00 per person including morning refreshments and course materials.

Group Discount
If a company wishes to register multiple people, the first two persons' registrations are $395.00. All subsequent registrations are $345.00 per person. To receive the discount, you must register all your attendees at once.

Add the first person, click Next which will take you to the Registration Summary page and click the "Add a Group Member" button. Then add the second the same way. When you input the third person or other additional people, their registration fee will be $345.00. When you’re finished registering everyone, click Next and go to the Order Summary page. Add your credit card information and press Submit.

TO REGISTER, GO TO

https://cvent.me/meEwAD?RefId=HSNGWGLT3G2

For questions, contact Nan Matthews, 303-843-6414 or Email BEFORE starting your group registration in order to enter the information correctly.

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