Welcome to this week’s edition of Warning Letter of the Week (WLOTW)! We will be explaining an FDA Warning Letter given to Abbott Point of Care (POC) related to their product “i-STAT cTnI Test”.
The warning letter covers issues with design control and 510(k) clearance while including one of the funniest lines I have read in an FDA Warning Letter (full Warning Letter).
If you want to learn more about Warning Letters, check out FDA Warning Letters: Everything You Need to Know.
This article will give a brief overview of the Warning Letter, then dive into some of the specific issues and lessons that can be learned.
Table of Contents
Quick Overview of Warning Letter for Abbott POC
The Warning Letter was given to Abbott Point of Care related to their product “i-STAT cTnI Test”, which is used to measure “cardiac troponin I in whole blood or plasma” and is a Class III medical device. Given the nature of the product, this is classified as a Medical Device and is subject to FDA clearance and GMP regulations.
The Warning Letter states that Abbott Point of Care did not give the FDA proper notification about modifications made to the device over a period of twenty years.
It references four different changes made to the product that could have an impact on the “safety or effectiveness” of the device. As the modifications could result in changes to the safety or effectiveness, Abbott was required to submit “a new premarket notification (510(k))” for each change.
Because Abbott did not submit the new 510(k)s, the device “is no longer considered to be substantially equivalent to the predicate devices described in your existing 510(k)s”.
For those of you who do not know, a medical device company can submit a 510(k) notification when they want to bring a product to market by demonstrating that it is substantially equivalent to a predicate (existing) device. However, once the 510(k) is submitted the company may have to resubmit the notification if there are significant changes to the device which make the device different than the original predicate device.
The Warning Letter also lists two findings related to violations of the medical device regulations 21 CFR Part 820, which are both related to design control.
The first finding was related to Abbott POC not “comparing the performance of the modified device change(s) to the originally cleared device either through design controls or regulatory review”.
The second finding was related to Abbott POC not being able to provide the initial design documents for the device.
If you would like to learn more about the findings, continue on in the article. Otherwise, that was a brief explainer of what was found in the Warning Letter issued to Abbott POC. There is nothing particularly scandalous found in the letter, and design control is one area that generates a decent amount of form 483s and FDA Warning Letters.
Deep Dive into Findings
Let’s dive a bit deeper into the findings from a regulatory perspective.
There is not much more detail needed for the initial findings about not submitting new 510(k) notifications for the design changes. If you want to get the specifics about the design changes check out the full Warning Letter.
First Finding
The first GMP-related finding was for Abbott POC not adequately establishing and maintaining design control procedures. It’s easy to see this finding coming based on the initial findings related to design control. If the modifications to the device are not triggering the submission of a 510(k), then how can the process be functioning properly?
Specifically, the FDA Warning Letter states that Abbott “did not consider the cumulative effect of design changes over time and never compared the performance of the modified device change to the originally cleared device“.
Part of the issue is that there were so many changes over the twenty years that it makes it more difficult to compare the current device to the originally cleared device. If the company had submitted a new 510(k) after each change, it would have been easier to compare any new changes to the cleared version of the device.
This difficulty can be seen in Abbott’s response. Abbott sent the FDA a comparison of the current device specifications to the originally cleared device specifications.
However, the FDA did not find that Abbott’s response was adequate. They found that the testing method did not determine sufficient accuracy, and that “the testing used to support your firm’s claims did not impact the performance of your device did not include a comparison of the modified device to the original device and key performance data such as clinical accuracy were not documented to support these design changes.”
Again, Abbott had a very difficult task due to the number and impact of the design changes over the years.
Second Finding
For the second GMP-related finding, Abbott was not able to provide the initial design documents for the medical device.
Why couldn’t they provide the documents? Because “the person in charge of storing the cartridge design history files had retired from the company and your firm had been trying to locate the person in retirement to try to find where the original design files (were) stored“.
This is one of the funniest and most relatable lines I have ever seen in a Warning Letter. This is something that could be a possibility at an enormous number of medical device companies, depending on who was going to retire.
It’s also a situation that a lot of companies do not even consider. Over such a long period, I’m sure many different design engineers, document control managers, and quality personnel have been in and out of the company. Most probably assumed that the information was available or that it was someone else’s job to know where the documents were located.
The finding highlights the need for medical device companies to have sufficient backup plans for when employees retire. This could also likely be avoided if the company had all of the information in a searchable document management system or eQMS.
For what it’s worth, Abbott POC did end up locating the document, although the location was not referenced in their “Quality Record Storage Procedure”. Abbott also updated their documentation procedures, installed a new file cabinet, and trained employees on the new procedure.
Lessons Learned
The goal of the Warning Letter of the Week articles is to learn about different mistakes in the eyes of the FDA and try to avoid those mistakes in the future. Let’s look at some of the important lessons that can be learned from this warning letter.
- Understand the requirements for submitting a new 510(k) notification. This means that a company needs to consider what changes to its device would cause a change in the safety and effectiveness of the device. It also means a company needs to have a process in place to submit new 510(k) notifications as part of its change control procedure.
- Consider the effect of cumulative design changes on a device. This is more specific given the nature of the findings, but it is still useful to keep in mind. If a company is constantly changing a device, it is good to consider how all of the changes impact each other to change the original device.
- Know where documents are located. The FDA may inspect a medical device company at any point based on the risk of their device. Companies need to be able to provide all relevant documentation if requested by the FDA. It’s also a good idea to have the locations correctly referenced in procedures so that a company does not find itself in the position of calling retired employees.
Wrapping Up
We hope you enjoyed this week’s WLOTW article. It was not the most salacious Warning Letter, however, there was still useful information on how to deal with design control and employees retiring. If you want to learn about other interesting Warning Letters, be sure to sign up for the newsletter below.
As always, if you have any questions or thoughts on this Warning Letter, feel free to leave them in the comments below.