The Food and Drug Administration ("FDA") has greatly
increased its activity around cybersecurity initiatives and medical
devices. As we approach the end of the year, this is a great
opportunity to review recent developments.
FDA Medical Device Cybersecurity Guidance
On October 18, 2018, the FDA published
draft guidance, "Content of Premarket Submissions for
Management of Cybersecurity in Medical Devices." This draft
replaces prior guidance from 2014, and the outlines recommendations
for device design, data confidentiality, labeling conventions, and
cybersecurity documentation. Key requirements include:
- Risk-based categorization of devices into two tiers (based
primarily upon device connectivity and risk of cybersecurity
incidents);
