- Why Us
The "Consolidated Appropriations Act of 2023" (more commonly referred to as the Omnibus Act) was passed and signed into law on December 29th, 2022. This amendment to the Food and Drug Cosmetic Act has expanded the scope of the FDA beyond just "safety and efficacy" to include the cybersecurity of medical devices. This amendment resembles a watered-down version of the PATCH Act, which failed to pass in late 2022.
As a result, on March 29, 2023, the FDA gained the legal authority to define and enforce medical device cybersecurity. So for today’s episode, we got THE leading minds in MedTech cybersecurity together to discuss what we need to do next. Chris Gates, Director of Product Security at Velentium, Chris Reed, Vice President of Product Security at Medtronic, and Ken Hoyme, CEO of Dark Star Consulting, join the podcast today to discuss the new guidelines, what the FDA can and can’t say about it, and what kinds of deficiencies you’ll be seeing in the future because of the new legislation.
How the FDA tried to clear a path for routine patches and updates
The minimum that the omnibus bill is talking about
No longer needing to make the link between cybersecurity and safety and effectiveness
When they have the legal authority to enforce cybersecurity
Why the document took so long to go through
Security architecture analysis
Why you should be referencing the April 2022 draft
Unpatched vulnerabilities at the time of submission
The effort needed to understand the FDA’s intentions
“Literally, if you’re not aware of this already, you’re already behind the 8-ball right now and there’s things you’ve got to do.”
“Basically, if you think it might be a cyber device, it is a cyber device.”
“Don’t sit there and try to be pedantic about this and say “I don’t need to do this because there’s a comma here.” It ain’t gonna work for you.”
“A synonym for threat modeling really is security architecture analysis.”
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...