SUMMARY
A Summary of FDA Premarket Submission Documents
Cybersecurity in Medical Devices
Practical Advice for Meeting FDA’s Requirements
Cybersecurity in Medical Devices
The goal of our document titled Cybersecurity in Medical Devices – Practical Advice for Meeting FDA’s Requirements - Summary of Premarket Submission Documents, which is available for download, is to help you prepare the cyber-relevant portions of your premarket submissions for the FDA.
It provides a summary of all the submission documents the FDA requires and provides practical advice on the activities that these documents are based on, drawing on information from the FDA’s guidance documents, the help sections of the eSTAR submission form, IEC 81001-5-1 standard for a Secure Product Development Framework (SPDF), and AAMI SW96 risk management standard. It is a complement to BG Networks’ Practical Advice webinar series which you can watch on-demand or sign up for the next to be presented.
For Quick Reference: A number of tables are included that summarize the 14 submission documents that are listed in Appendix 4, Table 1 of the Guidance. The intent is to give you a quick-reference for the documents and information that the FDA is asking for.
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The Cybersecurity in Medical Devices – Practical Advice for Meeting FDA’s Requirements - Summary of Premarket Submission Documents.
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Webinar Series Cybersecurity in Medical Devices –
Practical Advice for FDA’s 510(k) and PMA Cybersecurity Requirements.
The 10 Steps
In this document there are 10 steps presented in the order they ideally should be worked on. For example, it is best to first establish a Secure Product Development Framework, then create a threat model, perform a risk assessment, then create architectural views, etc… By performing these tasks in the order shown, the correct cybersecurity and most efficient approach will be taken. This order is different from the order of documents listed in Appendix 4, Table 1, in the FDA’s Cybersecurity In Medical Devices : Quality Systems Consideration and Content of Premarket Submissions (the Guidance). There, the order is primarily based on documents that have shared information (e.g., the Cybersecurity Risk Report summarizes information from the risk assessment, SBOM, vulnerability assessment, and unresolved anomalies assessment documents).
If you need assistance with the first step, establishing a SPDF, BG Networks offers services and a documentation package to help you establish a SPDF that is based on FDA recognized consensus standards.
