FDA

The FDA has announced the availability of the draft guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” The need for effective cybersecurity to ensure medical device functionality and safety has become more important with the increasing use of wireless, internet- and network-connected devices, portable media (e.g., USB or CD), and the frequent electronic exchange of medical device-related health information.

Two chemical companies purposefully kept the dangers of a toxic chemical found in food packaging hidden from the FDA, in effect, exposing millions of Americans to the substance. And now, the organization is working to phase it out.