All,

Bear with me please as I'm new to the quality assurance field. I apologize for the length, but I'm very confused over the relationship between reports of corrections and removals and MDRs.

Specifically, the regulation states that a manufacturer must report corrections/removals if these corrections were taken to reduce a risk to health. "risk to health" is defined as follows:

(1) A reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death; or
(2) That use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote.

Now - re: section 803. A manufacturer is required to submit an MDR report if the device may have caused/contributed to death OR if the device malfunctioned and this malfunction would be likely to contribute to or cause death or serious injury if the malfunction were to recur. In this case, we're talking about "serious injury" which is defined as life threatening, permanent impairment/damage to a body function/structure, or necessitates medical/surgical intervention to prevent such a permanent injury.

Here's where I struggle. I receive a customer complaint on a malfunction and perform a health hazard assessment. The result of this health hazard assessment is that the type of injury the malfunction could potentially cause is "temporary or reversible injury requiring medical intervention" (such as administration of additional medications or antibiotic) - and that the likelihood of harm is either rare or unlikely due to standards of clinical practice, how detectible the malfunction is, amongst other considerations. In the end we determine that the risk level is "acceptable".

In the meantime, an engineering change request has been submitted for the malfunction. Engineering decides to go ahead and fix the malfunction in an upcoming product release. Now, all of a sudden, they evaluate the correction for reportability under 806 and given the difference in definitions of injury in the two sections, it comes out that we should report the correction under 806! i.e., The malfunction won't cause SERIOUS injury as defined under 803, but it does pose a "risk to health" as defined under section 806.

Of course, we never submitted an MDR for the malfunction because it wasn't reportable under 803. Should we submit an MDR for the complaint in this case? If so, it will now be late because the correction was initiated months later.

Is there any relationship between 806/803 reporting other than the fact that when you submit an 803 you can also submit the 806 correction report at the same time on the same form? Or, to word it differently, do you have to have an MDR for every report of correction and removal? Are we doing something inherently wrong here?

I'm thinking that if we determined that the malfunction had an 'acceptable' risk level that we are saying there is no risk to health and therefore the correction should not be evaluated for 806 repotability?

Thoughts, advice would be so appreciated!

Thanks,
abpmom2

No need to be confused. But I think you need to step back and analyze the situation a little more.

I have seen this sort of situation before a couple of times, but it is unusual. I do have a question for you. Why was the engineering change classified as a correction? It would only be a correction if units in the field were changed. If not, then I think the exemption at 21 CFR 806.1(b)(1) would apply.

But for discussion, lets assume that the products in the field were changed, and an evaluation under 806 was necessary. This would be separate and independent of your complaint evaluation under 803. It is appropriate to do both evaluations. I would not use the 803 evaluation as justification for not evaluating under 806.

As for the forms being connected and similar, you do not need to file an MDR for every correction/removal, and not every MDR will need a correction/removal; they are linked but independent.

We make a lot of 510(k)ed devices, but we've never had a change to a device because of a risk of patient harm. So, if I may ask a possibly related question:

FDA guidance K97-1 says "...manufacturers need to submit a new 510(k) only when a change, or the sum of the incremental changes exceeds the §807.81(a)(3) threshold, 'could significantly affect the safety or effectiveness of the device.'" (http://www.fda.gov/cdrh/ode/510kmod.html)

The FDA doesn't provide any explicit clarification of their intent regarding 803 and 806. Our internal belief is that any 510(k)ed-device change that is made to address a risk identified via an incident or internal analysis that leads to either an 806 report or an 803 report, should get a 510(k) Special.

Thoughts?

21 CFR 803 (MDR) supplements 21 CFR 820 (QSR) (actually 21 CFR 820.198- complaints). Whereas, 21 CFR 806 (CAR) supplements 21 CFR 7 (Voluntary Recalls).

The data from both (inter-twined with product listings) are used by FDA for post market surveillance trending- risk based (such as pertaining to the old health hazards associated with the silicone breast implants some years ago).

Even though they may use the same terms and are "risk based", not all 21 CFR 806.10 corrections and removals come about from 21 CFR 803 MDR complaint investigations/ CAPA's (and visa versa).

During the complaint/ MDR investigation (based upon risk analysis/ risk management), one feels that a correction or removal (i.e. recall) is needed, then 806.10 applies. In other instances, if individual internal or external nonconformances (such as a MDR complaint)/CAPA's or through CAPA source data analysis, there is a need to have a product correction or removal (i.e. a correction not corrective or preventive action), then 806 applies. If it is determined that the correction or removal was conducted due to a risk to health, then the CAR has to be reported to FDA within 10 working days per 21 CFR 806.10.