Ad blocker interference detected!
Wikia is a free-to-use site that makes money from advertising. We have a modified experience for viewers using ad blockers
Wikia is not accessible if you’ve made further modifications. Remove the custom ad blocker rule(s) and the page will load as expected.
The need for effective cybersecurity to assure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and network-connected devices, and the frequent electronic exchange of medical device-related health information.
This guidance was developed by the FDA to assist industry by identifying issues related to cybersecurity that manufacturers should consider in the design and development of their medical devices as well as in preparing premarket submissions for those devices.
A draft of this guidance was published in June 2013.
- ↑ Content of Premarket Submissions for Management of Cybersecurity in Medical Devices-Draft Guidance for Industry and Food and Drug Administration Staff.