CFSN Detailed Analysis

Share this post

User's avatar
CFSN Detailed Analysis
FDA Publishes ‘Refuse to Accept’ Policy Guidance Document
Copy link
Facebook
Email
Notes
More

FDA Publishes ‘Refuse to Accept’ Policy Guidance Document

Patrick Coyle
Mar 31, 2023
∙ Paid

Share this post

User's avatar
CFSN Detailed Analysis
FDA Publishes ‘Refuse to Accept’ Policy Guidance Document
Copy link
Facebook
Email
Notes
More
Share

The Food and Drug Administration (FDA) published a notice of availability in the Federal Register (88 FR 19148-19150) for “Cybersecurity in Medical Devices: Refuse To Accept Policy for  Cyber Devices and Related Systems Under Section 524B of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff”. The actual guidance document is avai…

Keep reading with a 7-day free trial

Subscribe to CFSN Detailed Analysis to keep reading this post and get 7 days of free access to the full post archives.

Already a paid subscriber? Sign in
© 2025 Patrick Coyle
Privacy ∙ Terms ∙ Collection notice
Start writingGet the app
Substack is the home for great culture

Share

Copy link
Facebook
Email
Notes
More