# FDA Draft Premarket Guidance

DevFeed: [FDA Draft Premarket Guidance](<https://devfeed.tech/articles/fda-draft-premarket-guidance-36790.md>)

Original publisher: [Read original article](<https://shostack.org/blog/fda-premarket-draft/>)

Author: Adam

Published: 2022-04-08T00:00:00Z

Content type: news

Language: en

Sources: [Shostack & Friends Blog](<https://devfeed.tech/sources/shostack-friends-blog.md>)

Topics: [Security](<https://devfeed.tech/topics/security.md>), [Cybersecurity](<https://devfeed.tech/topics/cybersecurity.md>)

Tags: [cybersecurity](<https://devfeed.tech/tags/cybersecurity.md>), [healthcare](<https://devfeed.tech/tags/healthcare.md>), [medical-devices](<https://devfeed.tech/tags/medical-devices.md>), [security](<https://devfeed.tech/tags/security.md>)

## AI overview

The FDA has issued draft guidance on cybersecurity in medical devices, covering quality system considerations and the content of premarket submissions. Comments are due within 90 days.

## Source excerpt

The FDA has issued draft guidance for pre-market security