How to Prepare a Medical Device 510(k) Submission for the FDA

Long-time readers won’t be surprised my dear friend, regulatory expert Robert Packard, is back with this free FDA pre-submission workshop.

Rob writes, “FDA made a lot of changes to the 510(k) process since our last webinar together, Joe. I can cover some imminent changes and assemble a completely updated presentation, with new tips and tricks I learned from doing dozens of pre-subs since then.”

Among the topics we’ll cover:

• Changes to RTA process
• Human Factors Guidance
• Changes to eCopy process
• Small Business Qualification Changes
• Interoperability Guidance
• eSubmitter software status
• Device Modification Guidances
• Quik 510(k) Pilot
• Impact of De Novo & Fee Changes
• Cybersecurity Policies
• UDI Requirements
• New ISO 10993-1:2018 Standard

I like making things easy for you and registering for this content is a no-brainer for anyone who makes 510(k) submissions to FDA.

Trust me on this one. 😉

Presenter

Rob Packard
Founder and Instructor
Medical Device Academy

Moderator

Joe Hage
Leader of the
Medical Devices Group
(350,000+ members)

About the Medical Devices Group

The Medical Devices Group is the world’s largest medical device community and the industry’s only spam-free, curated forum for intelligent conversations with medical device thought leaders. Meet us at an upcoming 10x Medical Device event!

Medical Device Academy

Medical Device Academy, Inc. provides solution-based regulatory consulting and continuing education training services to medical device manufacturers. Clients that have urgent needs where time to market is critical, turn to us. Our passion is teaching medical device professionals how to prepare for future regulations and self-monitor compliance so that they can avoid compliance remediation.