510(k) Premarket Notification Workshop – Bringing Medical Devices to the U.S. Market

  • Overview
  • Sample Agenda
  • Learning Outcomes
  • Who Should Attend?
  • Trainer Profile

A one-stop shop for clearance and compliant marketing of your medical device through the 510(k) program. This premarket workshop provides a comprehensive overview of one of FDA’s main premarket programs – the premarket notification, or 510(k), program. The majority of medical devices sold in the U.S. are cleared for marketing under this program, and knowing how to navigate its requirements is critical to a successful regulatory outcome.

Sample Agenda

The agenda for our medical device training class might look like this:

  • Welcome and introductions
  • 510(k) basics, including variants of the 510(k) pathway
  • Constructing a 510(k) submission
  • Deciding when to submit a new 510(k) for device modifications
  • Communicating with FDA – Pre-Submission Program
  • Questions and answers

Learning Outcomes

NSF’s team of experts will provide participants with a hands-on approach to understanding 510(k) basics, including how to construct a complete 510(k) submission, from the perspective of a former FDA reviewer. This workshop also provides insight on how to communicate effectively with FDA via the Pre-Submission process, and takes you a step further on what to do when you have a cleared 510(k) device that needs modification, while considering risk management principles.

Who Should Attend?

This course is vital for any medical device regulatory professional, as well as directors, managers and engineers.

Trainer Profile

NSF's courses are taught by experts who have years of experience in medical device quality standards and regulatory requirements. Our trainers are committed to creating a learning environment that is highly interactive and based on real scenarios to help you apply practices and improve behaviors within your workplace. Learn more about our trainers for this course:

Upcoming Courses & Webinars

In 510(k) Premarket Notification Workshop – Bringing Medical Devices to the U.S. Market