For Immediate Release
March 18, 2020
Contact
Gavin Stern, gstern@aami.org 1-703-647-2781

AAMI Offers Webinar and Course for Navigating FDA’s 510(k) and De Novo Requirements



Preparing your own 510(k) premarket submission to the Food and Drug Administration can be a daunting task. That’s why AAMI has developed a new training course, Navigating 510(k) & De Novo Requirements course, designed for anyone responsible for preparing regulatory submissions to the Food and Drug Administration (FDA).

A proper understanding of the FDA’s 510(k) and De Novo premarket submission processes can help ensure a more cost-effective and timely market launch for medical device manufacturers.

On March 26, a free webinar will outline the difference between 510(k) and De Novo application processes and their benefits, as well as 15 “need-to-know” factors to be successful in both 510(k) and De Novo submissions.

“One of the things that makes this course different from others on the market is its coverage of the De Novo submission process,” said Rob Packard, of the Medical Device Academy, who will host the webinar. “Other courses don’t include this information because very few devices cleared by the FDA each year require a De Novo submission.”

The first three days of the four-day program will cover the 510(k) process. Content will be divided into 15 modules that follow the FDA’s requirements for 510(k) premarket submissions. Attendees will work in small teams to find information in FDA databases that they can later use for their own device submissions. The De Novo-specific sections of the premarket submission process will be discussed during the last (and optional) day.

During the course, attendees can expect to learn how to identify the appropriate U.S. regulatory pathway for their devise, identify a predicate device, and create a testing plan for their premarket submission. Content for the course includes quality system requirements, design controls, and testing requirements for all types of devices.

To register for the 510(k) & De Novo Requirements webinar and course, visit the AAMI Store.

All classes for the remainder of the year are open to virtual attendance. Virtual attendance will allow for: Live interaction with classmates and instructors Hands-on learning with devices mailed to your location Digital access to all course content AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at http://zoom.us/test.


AAMI (www.aami.org) is a nonprofit organization founded in 1967. It is a diverse community of more than 9,000 healthcare technology professionals united by one important mission—supporting the healthcare community in the development, management, and use of safe and effective health technology. AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for health technology and sterilization professionals.