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

V

vivekcek

#1
#1
Hi

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

Could anyone provide me templates
 
Quickly Organize an Intelligent TDP from DISCUS
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#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
#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
#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Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff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
 
Y

yodon

Staff member
Super Moderator
#6
#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
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Watchcat 510(k)s and "Innovation"? Other US Medical Device Regulations 2
D Change to labelling - does it require a new 510(k)? US Food and Drug Administration (FDA) 3
A How can we change a device trade name in 510(k) summary? US Food and Drug Administration (FDA) 0
K PMA vs 510(k) for Mammography Machine US Food and Drug Administration (FDA) 2
S Predicate Material 510(k) US Food and Drug Administration (FDA) 1
S Predicate Material 510(k) Medical Device and FDA Regulations and Standards News 3
J US Device Listing when not the 510(k) owner Medical Device and FDA Regulations and Standards News 2
supadrai Possible to Submit a 510(k) if you have never, do not and cannot produce the device for which you're submitting the application? US Food and Drug Administration (FDA) 4
S Special 510(k) for orthopedic implant 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Label change - 510(k) Medical Device and FDA Regulations and Standards News 5
G We want to add Covid-2 /19 to our air filter 510 K Medical Device and FDA Regulations and Standards News 0
A The refund of 510(k) user fee Medical Device and FDA Regulations and Standards News 0
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
A 510(k) review timeline 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
L Impact on 510(k) to use an additional manufacture US Food and Drug Administration (FDA) 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
Watchcat Advantages to pursuing a Special 510(k) instead of a Traditional 510(k) Other US Medical Device Regulations 5
A 510(k) registration and listing US Food and Drug Administration (FDA) 1
Aymaneh Traditional 510(k) Declaration of Conformity Other Medical Device Regulations World-Wide 3
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
A Several sections of traditional 510(K) have the same or similar requirement of content. US Food and Drug Administration (FDA) 4
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
A Some doubts about traditional 510(k) submission US Food and Drug Administration (FDA) 5
A Bench test report translation to English for 510(k) submission Other US Medical Device Regulations 2
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Y Expanding the indications for use for a 510(k) cleared device Medical Device and FDA Regulations and Standards News 4
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 4
T Submitting MR Compatibility Data for 510(k) Cleared Device Other Medical Device and Orthopedic Related Topics 2
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
Z 510(k) usage - Company has 2 physically similar products Medical Device and FDA Regulations and Standards News 2
K 510(K) File eCopy Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
Q Need clarification on requirements.... Class i, gmp & 510(k) exempt Medical Device and FDA Regulations and Standards News 12
D Redacted 510(k)s - Example wanted Document Control Systems, Procedures, Forms and Templates 17
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Completing Design Controls after 510(k) Clearance Other US Medical Device Regulations 11
P Predicate Device Information for 510(k) Submission Medical Device and FDA Regulations and Standards News 4
M 510(k) 10993 Biocompability Testing Other US Medical Device Regulations 15
D First 510(k) Submission - Don't Forget Tips US Food and Drug Administration (FDA) 5
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
K Mammography Machine Bench Testing - FDA 510(K) US Food and Drug Administration (FDA) 5
D Is Human Factors testing mandatory for a 510(k) submission? Human Factors and Ergonomics in Engineering 16
D Pre-Submission after 510(K) Submission? Other US Medical Device Regulations 4
M Informational US FDA Final Guidance – Special Premarket Notification [510(k)] Pathway Medical Device and FDA Regulations and Standards News 0
M CBE (Change Being Effected) 510(k) Submission Other US Medical Device Regulations 2
K 510(K) Submission (Traditional) for Medical Device US Food and Drug Administration (FDA) 17
F Replacement Bone Screws - Traditional 510(k) or Special 510(k)? Other US Medical Device Regulations 7
M Informational US FDA Final guidance – Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions Medical Device and FDA Regulations and Standards News 0
Watchcat Informational FDA Proposal to "Modernize" the 510(k) - 2019 Other US Medical Device Regulations 1
B 510(k) clearance claim on medical device product packaging Other US Medical Device Regulations 6

Similar threads

Top Bottom