510(k) Raw Data from Studies - 21 CFR Part 11 Compliance

invitro_spain

Involved In Discussions
#1
Hi Folks,

I need help for this easy or not so easy question. During the premarket submission for a device Class II-Moderate risk, you have to include a summary of your bench studies and raw data (for example, spreadsheets with the data from your studies).

In this case, Should these spreadsheets comply with the 21 CFR Part 11?

Could you advise me about the most suitable way to comply with this regulation?

Thank you in advance
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
If the spreadsheet is maintained as an electronic record or if you applied a signature electronically as required by predicate rule then yes!

Further, a spreadsheet application should also be validated for its intended use. If the spreadsheet is not validated then the data collected COULD be called into question.

A lot will depend on your inspector. The "enforcement discretion" can be anywhere in the spectrum. One option is to make a snapshot of the spreadsheet (PDF) and control that as the record. (There's still potentially a Part 11 concern but it's greatly reduced since alteration would be much more difficult. And the validation concern still exists, too.)
 

invitro_spain

Involved In Discussions
#3
One option is to make a snapshot of the spreadsheet (PDF) and control that as the record. (There's still potentially a Part 11 concern but it's greatly reduced since alteration would be much more difficult. And the validation concern still exists, too.)
Thank you yodon. Sorry for the delay in replying. During the submission, you have to submit a hard copy and a electronic copy of your 510(k) using "esubmitter". I suppose if you upload a spreadsheet to this application you may obtain a pdf controlled version of your initial spreadsheet. Anyway, you can include a hard copy version signed in paper with your 510(k). Would be this methodology correct?
 

Mark Meer

Trusted Information Resource
#5
...I suppose if you upload a spreadsheet to this application you may obtain a pdf controlled version of your initial spreadsheet. Anyway, you can include a hard copy version signed in paper with your 510(k). Would be this methodology correct?
We use this method - spreadsheets, once finalized, are exported to PDF, and then signed. Alternatively, the exported data is attached to a test-report as an appendix, and it is the report that is ultimately signed and controlled.

This should be done at the time the data is done (record closed). The original spreadsheet can be maintained/archived, but as far as your records go, the signed PDF of the data is the "official" record.

Signatures are intended to attest to some activity (e.g. review, approval..) at the time of the activity. So, exporting a PDF and signing it long after the spreadsheet was originally finalized, just for the purposes of Part 11, and a 510(k), may be called into question.

Alternatively what you can do is to collect required signatures elsewhere (e.g. via a separate approvals form). In such case, all you have to do is:
1. Make sure that the dates on the signatures form are after the last modification date of the spreadsheet.
2. The spreadsheet is protected somehow from modification (or, at least, a way to identify modification - e.g. via timestamps, version control), after the necessary signatures have been collected.
 
Thread starter Similar threads Forum Replies Date
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
A 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 5
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 1
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
Kuldeep Singh 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 14
Kuldeep Singh 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
Kuldeep Singh 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
Kuldeep Singh 510(K) Submission (Traditional) for Medical Device US Food and Drug Administration (FDA) 15
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
shimonv Referring to previously submitted biocompatibility results in a new 510(k) submission Other US Medical Device Regulations 1
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
B Submit a 510(k) with a Predicate cleared but not Listed US Food and Drug Administration (FDA) 9
R 510(k) Biocompatibility vs Cleaning Validation Other Medical Device Related Standards 4
Kuldeep Singh Change of Existing Medical Devices and 510(k) US Food and Drug Administration (FDA) 9
S Where did FDA 510(K) form 3654 go? Other US Medical Device Regulations 1
M Has anyone here assessed the latest Abbreviated 510(K) guidance document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Informational USFDA – Refuse to Accept Policy for 510(k)s Medical Device and FDA Regulations and Standards News 1
K 510(k) expanding the indication for use for a cleared device Other US Medical Device Regulations 9
P 510(k) cleared, Rx only and home use 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
lilybef Number of lots required for stability testing of a Class II device in the 510(k) Qualification and Validation (including 21 CFR Part 11) 3
T Executive summary for Traditional 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
M FDA News US FDA – November 2018 510(k) Clearances Medical Device and FDA Regulations and Standards News 0
M FDA News FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program Other US Medical Device Regulations 0
M Medical Device News FDA - Transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices Other US Medical Device Regulations 0

Similar threads

Top Bottom