510(K) Cyber Security Documentation for Pre-market Submission (Templates)

V

vivekcek

#1
Hi

I need to prepare the cyber security documents for pre-market submission.

Could anyone provide me templates
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: 510(K) Cyber Security Documentation

Hello and welcome to the Cove :bigwave:

Why do you think you need to include such documents in your submission?

Ronen.
 
V

vivekcek

#3
As per new rule along with other documents we need to submit

Cybersecurity Documentation
The type of documentation that we recommend you submit in your premarket submission is summarized in this section. These recommendations are predicated on your effective implementation and management of the quality system in accordance with the Quality System Regulation, including Design Controls.6

In the premarket submission, manufacturers should provide the following information related to the cybersecurity of their medical device:

Hazard analysis, mitigations, and design considerations pertaining to intentional and unintentional cybersecurity risks associated with your device, including:
A specific list of all cybersecurity risks that were considered in the design of your device;
A specific list and justification for all cybersecurity controls that were established for your device.
A traceability matrix that links your actual cybersecurity controls to the cybersecurity risks that were considered;
To assure continued safe and effective device use, the systematic plan for providing validated updates and patches to operating systems or medical device software, as needed, to provide up-to-date protection and to address the product life-cycle;
Appropriate documentation to demonstrate that the device will be provided to purchasers and users free of malware; and
Device instructions for use and product specifications related to recommended anti-virus software and/or firewall use appropriate for the environment of use, even when it is anticipated that users may use their own virus protection software.
 
V

vivekcek

#5
Please google

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff

In U.S Food and drug administration website.

i can't post link here
 

yodon

Staff member
Super Moderator
#6
I would suggest dealing with it through risk management. Possibly even creating a separate FMEA for cybersecurity. That will cover the list of items considered. Controls will be defined to mitigate risk and facilitate traceability.

Things get tricky pretty quickly when you incorporate SOUP/COTS. You may have to have procedures to do malware scans before deploying. I would document those efforts / outcomes in a version description document.

Here's the link: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm356186.htm
 
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