The Food and Drug Administration has partnered with industry groups to develop standards meant to help medical device firms protect their technology offerings from cybersecurity threats, MassDevice reported Thursday.
Arezu Sarvestani writes the FDA released formal guidance last year recommending that manufacturers document their cyber risk management measures in premarket submissions.
The agency has built a new laboratory that will use a Codenomicon Defensics-made technology to screen medical devices for any vulnerabilities before the products are released on the market.
Melissa Masters, engineering manager at Battelle, believes medtech developers need to factor cybersecurity in early phases of device development.
“Everyone has seen the guidance document and, if they’ve been around for a while, they know what that means,” Masters told MassDevice.
“They know that in a year and or so, the FDA is going to start really looking through your filing and ensuring that you’ve done [security testing],” she added, according to Sarvestani’s article.