IVD Software Requirements - Editing of Patient Information

R

r_d_director

#1
I simply need to know if it is a violation of 21 CFR part 820 or any other FDA regulation for an in vitro diagnostic device software to allow patient information to be edited once it has been entered by the user (e.g. if the user realizes the patient ID# is incorrect or the name is misspelled). We are currently working woth two contract developers, both of whom claim to know FDA/ISO regulations, but who disagree on this point. One developer has no problem with it. The other says it is absolutely not allowed. Which one is correct?

Thanks in advance for your time.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Re: IVD software

So this sounds like the issue arises when the software is in 'production' use - correct? I don't think there's anything in 820 that would dictate any usage criteria. What may come into play is 21CFR Part 11 - Electornic Records / Electoronic Signatures. If that's the case then certainly there would need to be sufficient audit trails for such changes. They wouldn't be prohibited, but would require some data to be maintained.

A little scant on the details so it's hard to make a good assessment.

What element does the one contractor who says it's a violation cite as being violated?
 
R

r_d_director

#3
Re: IVD software

Thanks fot the prompt reply. Here is the scenario I'm asking about in more detail. Imagine a technician in a clinical lab, running patient samples on a typical in vitro diagnostic device, like an ELISA. The associated software prompts the tech to manually enter the patient/sample info and then start the analysis. The tech types in the info. and starts the analysis, only to realize he/she has typed in the wrong sample ID for one or more patients. Once the analysis is done, can the tech correct the sample ID? Or does that sample have to be reanalyzed?

I have not asked the developer who claims this is a violation to cite a specific rule. His explanation was that is was discussed at length with the FDA, and those were the recommendations.

Does this help clarify the question?

Thanks again for your help.
 

sagai

Quite Involved in Discussions
#4
Re: IVD software

Hi,
I agree with Yodon, I think there is no relation between your subject and 21CFR820 due to it regulates your QMS (simple saying the way you operate) only.
What shall be evaluated is that is there any regulation how you shall handle your patient data based on the classification of your software (medical device).
For more see:
http://www.fda.gov/MedicalDevices/D...dance/Overview/ClassifyYourDevice/default.htm
In case you have a class II device, there are special controls (Guidances) to conform with, see and determine the relevant ones:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm123682.htm

Actually coming back to your original question, I think this issue shall be addressed to your Risk Management, it shall be included into your Risk Management File, shall be evaluated/mitigated/verified with the others you enlisted among hazardous situations (hopefully you have it anyway).

Again, there may be special regulation out of the scope of the CFRs you shall apply in the US for Patient Data management, it shall be investigated or may someone can give us advice.

br
Sz.
 
R

r_d_director

#5
Re: IVD software

Thanks for the reply sagai. Yes, we have our Risk Management system in place, but if there is a hard and fast rule against editing patient info., Risk Management is irrelevant. Sounds like we need to keep digging, because there may be a requirement we are not aware of (outside of CFRs).

We have hired an ISO software specialist consultant, and this will be the first question I ask her. I'm trying to get advice from as many sources as I can at this point. If I get a definite answer, I'll post it back here for everyone's benefit.

Thanks again for your input.
 

yodon

Staff member
Super Moderator
#6
Re: IVD software

Since you're in the clinical data side of things now, I can only speculate. I would think, though, that there has to be an electronic analog to paper. What if the lab tech entered the data incorrectly using a paper-based system. Surely there would be the opportunity to correct it. I would presume Good Documentation Practices would apply, which would require the tech to mark out the original entry, correct the entry, initial / sign the change, and possibly explain the change. 21CFR Part 11 provides the analog for electronic records / electronic signatures. Such changes are allowed but the system must provide a sufficient audit trail to confirm who made the change and when it was made.

Looking forward to seeing what your hired gun says.
 
Thread starter Similar threads Forum Replies Date
H UDI (Unique Device Identification) Requirements for IVD Software EU Medical Device Regulations 2
W Requirements for using Open Source Software in Medical Devices - IVD Medical Device IEC 62304 - Medical Device Software Life Cycle Processes 10
H Software Interface Translation IVD Regulation EU Medical Device Regulations 0
D Software User Interface Languages for LVD and IVD CE Marking (Conformité Européene) / CB Scheme 2
M Reusing existing RUO Software for IVD Development 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Any violation with the use of RUO software with IVD instrument CE Marking (Conformité Européene) / CB Scheme 3
I Is Software an IVD Directive Classification? EU Medical Device Regulations 10
S IVD Device History Record ISO 13485:2016 - Medical Device Quality Management Systems 3
J IVD sampling sizes for buyer Reliability Analysis - Predictions, Testing and Standards 0
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
A CE-IVD Technical File with Multiple IFUs EU Medical Device Regulations 4
A Ethics Committee Review Process for IVD Products EU Medical Device Regulations 2
F IVD registration in EU - Northern Ireland based company EU Medical Device Regulations 0
J IVD registration renewal in China China Medical Device Regulations 6
S IVD risk class II devices for Brazil and MDSAP Other Medical Device Regulations World-Wide 0
A IVD in MDR procedure pack EU Medical Device Regulations 2
I IVD - 98/79EC - class IIa - Annex to the EC from the NB states the CM as one of the facilities? CE Marking (Conformité Européene) / CB Scheme 2
G CE marking of MD and IVD set EU Medical Device Regulations 3
D List A IVD - Change to material supplier EU Medical Device Regulations 3
D IVD (in vitro diagnostic) Labelling Requirements - 98/79/EC CE Marking (Conformité Européene) / CB Scheme 2
J IVD instrument as an accessory EU Medical Device Regulations 3
C Where to place CE/label in Sterile IVD EU Medical Device Regulations 1
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Watchcat ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 9
H Incomplete IVD kit under IVD Regulation EU Medical Device Regulations 1
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P Do I need to get registered or have German entity to sell IVD products in Germany? CE Marking (Conformité Européene) / CB Scheme 2
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 11
samarth IVD manufacturer and service provider ISO 14971 - Medical Device Risk Management 2
J Universal Power Cord with Adapters - IVD IEC 61010-2-101 CE Marking (Conformité Européene) / CB Scheme 6
M PMS template for FDA submission (De novo submission for a Class II IVD) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J IVD CE transfer to another manufacturer EU Medical Device Regulations 4
V CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing Other Medical Device Regulations World-Wide 3
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
M Informational TGA – European implementation of Medical Device and IVD Regulations – Implications for Australia Medical Device and FDA Regulations and Standards News 0
S How to consider the relevant standards during development of ISO13482:2016 for IVD manufacturing Blood grouping Other Medical Device Related Standards 6
M EU IVD Risk Determination of sample collection EU Medical Device Regulations 0
J Deciding between Professional Use or Lay Person IVD Test - Human fecal stool specimens Other Medical Device and Orthopedic Related Topics 1
D RUOs in IVD products Other Medical Device and Orthopedic Related Topics 2
P Usability/human factors engineering requirement (standard) for IVD medical device Other Medical Device Related Standards 2
M IVD Registration - Use of Prospective Study Data Other Medical Device Regulations World-Wide 1
R Medical Device (IVD) - Selling RUO to Customers EU Medical Device Regulations 2
I IVD prototypes in EU market ISO 13485:2016 - Medical Device Quality Management Systems 2
N Own brand labelling/virtual manufacture of IVD's EU Medical Device Regulations 2
M IVD - Generating clinical data for IVD’s in the EU EU Medical Device Regulations 2
K Validation of coating plate (IVD) CE Marking (Conformité Européene) / CB Scheme 3
I Another design change or new product? IVD device ISO 13485:2016 - Medical Device Quality Management Systems 6
B IVD or a general product test kit (if such a thing exists) EU Medical Device Regulations 0
T MDD and IVD comparison Other Medical Device Regulations World-Wide 2
T IVD - Self Declaration - Technical File - Template wanted Various Other Specifications, Standards, and related Requirements 9

Similar threads

Top Bottom