EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, the EduQuest staff provides insight into whether or not manufactured devices with non-conformances are both recordable and then reportable to FDA.
Question: We manufactured several hundred of our devices, approved them for release and distributed a dozen or so before we recognized in-house that some of the devices had minor non-conformances.
We performed a risk evaluation and determined that the risk to users was negligible, so we did not take action with products already in distribution. We did, however, re-work and re-inspect the units remaining under our control to identify and remove non-conforming units.
We don’t believe this action was reportable to FDA. However, is it a recordable event under 21 CFR Part 806, the rule for reportable medical device corrections and removals?
Answer: It’s definitely a recordable event and likely reportable, as well.
For the non-conforming devices still within your control, you must comply with the non-conformance, failure investigation and re-work requirements of the Quality System Regulation (21 CFR Part 820).
And, under 21 CFR Part 806.20, you must extensively document (record) all of those actions.
Further details on what else to include in those records are provided in Section 806.20(a) through 806.20(c).
Regarding the non-conforming product already distributed, you’re getting into a very shady area, despite your risk assessment.
We suggest that you don’t get into a situation where you’re splitting hairs with FDA by using such words as “negligible,” which certainly FDA could debate.
The only time something is not reportable under 21 CFR Part 806 is when the product absolutely cannot result in an adverse health consequence.
In other words, by not reporting the release, you are saying that no matter how, why or where the non-conforming product is used—and no matter what underlying medical conditions are faced by the patients—there’s no way that the non-conformance could result in an increased risk to patient health.
FDA holds all the cards, and it will second-guess your decision. That’s a fact of life in our industry. So, we advise you to err on the side of caution and report the product release, as well as record your internal corrections.