The FDA is in a constant state of working to optimize regulatory requirements for advancing technology. Digital health has been a hot topic for the agency over the past year due to increases in remote healthcare amidst the COVID-19 pandemic and advances in technology like AI/ML. Last week, the FDA named its first-ever acting director of medical device cybersecurity for the CDRH, Kevin Fu. The appointment of this position also correlates with the development of the FDA’s Digital Health Center of Excellence, which was launched last September to focus on the growing digital health industry.

1. Prioritizing Cybersecurity in the Med Device
Industry
By: Madison Wheeler
The FDA is in a constant state of working to optimize regulatory requirements for advancing
technology. Digital health has been a hot topic for the agency over the past year due to increases
in remote healthcare amidst the COVID-19 pandemic and advances in technology like AI/ML.
Last week, the FDA named its first-ever acting director of medical device cybersecurity for the
CDRH, Kevin Fu.1 The appointment of this position also correlates with the development of the
FDA’s Digital Health Center of Excellence, which was launched last September to focus on the
growing digital health industry.
Although we have barely just begun the 2nd month of 2021, the FDA has already made it clear
that cybersecurity/digital health is one of its focuses in 2021. Between the update to the AI/ML
Action Plan released last month, and now the appointment of a brand-new position aimed
directly at cybersecurity, 2021 is shaping up to be a big year for software as a medical device
(SaMD) products.
To many, this is a step in the right direction and shows the agency’s commitment to keeping up
with technological trends. Additionally, the cybersecurity focus is likely a response to the
vulnerabilities highlighted during the pandemic. There were several cases of reported
cybersecurity vulnerabilities last year, such as IBM’s issue with insulin pumps that could be
remotely controlled by hackers to alter medication dosages and manipulate readings from
monitors.2 No matter the reason, this is undoubtedly a step in the right direction for the FDA
and public health.
As the FDA diligently works to close the regulatory gap for digital health technology, the agency
will likely look to collaborate with industry to ensure regulations adequately protect public
health while simultaneously promoting technological advancement. I am willing to bet that 2021
will continue to be a year focused, among other things, on digital health and SaMD’s. Luckily,
the technical team at EMMA International is on top of the changing regulatory landscape and
can help make sure your team is up to speed! If you have a SaMD or other digital health product,
we can help make sure it is compliant. Give us a call at 248-987-4497 or email
info@emmainternational.com to get connected with us today!
1 University of Michigan (Feb 2021) Kevin Fu fillsnewleadership position atFDA’s center for devices and
radiological health retrieved on 02/08/2021 from: https://cse.engin.umich.edu/stories/kevin-fu-fills-new-
leadership-position-at-fdas-center-for-devices-and-radiological-health-overseeing-medical-device-security
2 Slabodkin (Aug 2020) Insulin pumps amongmillionsof devices facingrisk fromnewly disclosed cuber vulnerability
retrieved on 02/08/21 from: https://www.medtechdive.com/news/insulin-pumps-among-millions-of-iot-devices-
vulnerable-to-hacker-attacks/584043/