Warning letter examples for medical device companies related to the pharma guidance on data integrity?

Stoic

Stoic

Starting to get Involved
Does anyone know of any publicly available FDA warning letters issued to a medical device company for data integrity problems, specifically related to issues outlined in the pharma guidance document?

I'm looking specifically for cases in which the finding(s) relate to:
  • raw data in spreadsheets and control of changes to them (not anything about calculations and software validation), or
  • other raw data from measurement systems that is somehow transformed, reduced, or otherwise interpreted, and the source data is not preserved

I can find lots of examples from the pharma side, but so far none from CDRH.

Thx
 
T

Tidge

Trusted Information Resource
The following is written without searching for myself.

I think it would be very unlikely to find a warning letter specifically involving (direct) data integrity for medical devices, primarily because I find it hard to imagine a circumstance where the FDA would be looking at data in such a way that would bring the question of data integrity into focus. I can almost imagine this sort of question coming up during a submission. I anything like a QSIT (or even a targeted) inspection I would think a more likely focus would be on document control, record retention and possibly (if used) software validation.

Once a device is marketed, I am trying to imagine how a company would discover (or to invert this: leverage) a lack of (raw) data integrity as an issue (or feature!) of sloppy record keeping while making some sort of effort to comply with the general principles of the Act (that is, not be criminals). I feel like this would have to manifest itself in something like a CA system, or withing the complaints handling space.

If we aren't talking about simply bad document control practices or sloppy design verification, and are focused on some actual data that affects product/customers... perhaps there have been some warning letters involving manufacturing and/or service calibrations? The only other area I can think of is the realm of SaMD for devices themselves that could be defective in the area of data integrity (distinct from confidentiality) but nothing is coming to mind in the medical device sector.
 
C

Chrisx

Involved In Discussions
There are very specific data requirements in the pharmaceutical regulations, see 21CFR211.68. I have not found similar requirements in 21CFR820. I'm not guaranteeing some inspector might not take a different interpretations, but it does not seem to be as explicitly stated as it is in the pharma cGMPs. If data is falsified or otherwise mishandled and it resulted in the release of a dangerous medical device, I think FDA will find a way to take action.
 
chris1price

chris1price

Trusted Information Resource
As someone with a device background now auditing in the Pharma world, this has intrigued me for some time. I am not aware of any warning letters for device companies related to Data Integrity. Similarly, there is no guidance in the device section.

However I have seen a significant change in the last few years. Many device sub-contractors have started performing gap analyses, and at least one supplier of plastic parts I visited has a DI system as compliant as any pharma company. This will take time to feed through to smaller companies but any contractor who has contact with the pharma world will be expected to have DI policies in place in the near future.
 
C

Chrisx

Involved In Discussions
For companies that supply to both pharma and medical device or manufacture combination products, I can see this becoming establishes. However, as a purely device contract manufacturer, I have not had any customer inquire about data integrity. I have also not seen it required in any quality agreement. Without a requirement in the QSR, it seems unlikely to change anytime soon. It's in pharma, because it's required by 21CFR211.68.
 
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