Events

2026

RMRAS Annual FDA Update
Thursday, September 3, 2026
4:00 pm - 7:30 pm
PPA Event Center
2105 Decatur, Denver, CO 80211

 For more than 15 years, the Rocky Mountain Regulatory Affairs Society (RMRAS) has proudly presented the Annual FDA Update—our premier event and one of the most anticipated programs of the year. Since 2009, this event has provided a unique opportunity for professionals across the medical device, pharmaceutical, biotechnology, and life sciences industries to hear directly from representatives of the FDA's Denver District.

The Annual FDA Update has become a cornerstone event for our regional community. We are thrilled to bring this outstanding program back in 2026 and invite you to join us this September for an evening of valuable insights, professional development, and exceptional networking opportunities.

The FDA Panel includes:
E. Mark Harris
Acting Office Director
Office of Inspections and Investigations
Food Products Inspectorate, Office of Human Food Inspectorate West
Topic: Short welcome, local management and current organization/
 
Bryan J. Love               
Special Assistant, OMDRHI
Topic: QMSR Implementation and Current Update to Compliance Program Inspection of Medical Device Manufacturers
 
Matthew M. Vernon, PhD (BME)
Medical Device Specialist, OMDRHI
Topic: Commonly Encountered FDA-483 Citations to Identify Before FDA Arrives
 

Schedule:

4:00 – 4:30    Registration 
4:30 – 6:00    Presentation by FDA Panel                      
6:00 – 7:30    Networking with hors d'oeuvres and a cash bar

Sponsors:
On behalf of the Rocky Mountain Regulatory Affairs Society (RMRAS), we extend our sincere gratitude to our sponsors for their generous support.  We truly appreciate your commitment to our organization and to advancing professional education within our industry.  

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.
 

Topic Ideas?

Please send us your ideas for meeting topics, programs, classes, etc. Email info@rmras.org.