Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
December 28, 2016
March 7, 2019
31ce85d3-4c54-4d7e-907a-0fcf0670a843
Related Documents
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentSeptember 6, 2017Center for Devices and Radiological Health
Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentJuly 27, 2016Center for Devices and Radiological Health
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentApril 13, 2015Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox