Cybersecurity has become an increasingly important part of medical device development and, along with that, device regulation. FDA’s increasing awareness of this led to its creation of a new position within CDRH focused exclusively on this area, headed by Kevin Fu, one of the pioneers in this still-emerging specialty. Here he outlines the kinds of threats device companies face, and how industry and regulators can work together to protect both legacy and new products against such challenges.
Cybersecurity in medical devices was, at one time, a regulatory backwater in which regulators lagged behind parts of medtech and other industries in acknowledging this emerging challenge. More recently, however, FDA has made cybersecurity a priority in all sectors, including devices, putting regulators more on par with and in certain areas even ahead of the private sector in both recognizing and protecting against these threats.