19 Jan FDA posts cybersecurity guidance for medical device manufacturers
In addition to incorporating controls in device designs, makers must also consider ongoing improvements because risks could occur over the device’s lifecycle.
The Food and Drug Administration has issued draft guidance outlining steps medical device manufacturers should take to counter cybersecurity threats.
The agency offers advice on monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the market.
The draft guidance, published Jan. 15, is part of the FDA’s effort to ensure the safety and effectiveness of medical devices at all stages in their lifecycle, officials said. They note that in addition to incorporating controls in the design of the device, makers must also consider improvements during maintenance because risks could occur over the device’s lifecycle.