Editor’s Note: An advance copy of an FDA Federal Register notice requesting comment on a draft cybersecurity guidance document is attached here. There is a 90 day comment period. Below is the Summary statement.
From: Food and Drug Administration
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” This guidance identifies cybersecurity issues that manufacturers should consider in preparing premarket submissions for medical devices in order to maintain information confidentiality, integrity, and availability. This draft guidance is not final nor is it in effect at this time.
Leave a Reply