Navigating 510(k) and De Novo Requirements
This 4-day course will navigate the 510(K) clearance process and De Novo classifications requests for United States (U.S.) and global Medical Device Manufacturers and regulatory affairs leaders to improve the ability to bring new and improved devices to the U.S. marketplace.
Upcoming Virtual Courses
Regulatory
Navigating 510k & DeNovo Requirements (Nov25)
Nov 3 to Nov 6, 2025
Overview
In recent months, there has been an overhaul of software and cybersecurity 510(k) requirements. As of October 1, eSTAR submissions are required. This course will walk through the eSTAR template section by section so you know exactly what is required, how to use the form, and how to submit electronically. This 4-day course will navigate the 510(K) clearance process and De Novo classifications requests for United States (U.S.) and global Medical Device Manufacturers and regulatory affairs leaders to improve the ability to bring new and improved devices to the U.S. marketplace.
501(k) submissions have been significantly updated over the past year, and even the past few months. Everyone, including professionals with experience submitting 510(k)s will be able to benefit from the recent updates to this course.
Objectives
Identify when a 510(k) submission is required by the U.S. Food and Drug Administration, what medical devices are exempt from review, the various 510(k) submission types, and the processes for submitting 510(k) applications.
- Access FDA Guidance(s) and databases (e.g., Establishment Registration database) to find information provided by the FDA and public information about other devices that are legally marketed in the USA.
- Identify strategies for dealing with rapidly evolving medical device policies.
- Understand the specific format and content required by the FDA for all 510(k) submissions.
- Describe substantial equiveillance in terms of design, construction, use indications, safety performance, effectiveness, etc.
- Understand the basic requirements for documenting design controls, risk management and human factors validation during device design and development—including software development.
- Understand the FDA 510(k) review process—including eCopy uploads, RTA screening, substantive review, interactive review, and requests for additional information.
- Recognize how to reduce the time to bring new and improved devices to the U.S. marketplace and avoid common mistakes that lead to submission errors, rework, denial and delay of applications using the 510(k) clearance process.
- Understand the various types of pre-submission meetings, and determine how to get the most value from that FDA interaction during the Pre-Submission meeting
- Understand the basic process for registration and listing of a device that is 510(k) cleared, and when that occurs in the overall 510(k) process.
- Understand how to determine and document if device modifications require submission of a new 510(k)
- the De Novo pathway and how to prepare a De Novo submission.
What to expect
- Learn about all the elements and documentation required in a 510(k) submission.
- Plan your design project for 510(k) clearance.
- Reduce time to market through full regulatory comprehension and strategic planning
- Lower your company’s dependence on consultants by bringing the regulatory expertise in-house
Who Should Attend?
U.S. and global (e.g., European Union, Association of Southeast Asian Nations) quality and regulatory affairs leaders for Medical Device Manufacturers (MDM); MDMs of new device technologies, such as those developing mobile applications.
Virtual Training Information
Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.