Should corrective maintenance performed on a single device be evaluated for reportability?
A strict reading of the regulation would say yes, but I’ve never seen it done, nor seen a Warning Letter. The reportability criteria (reduce risk to health or correct a violation) are seldom met. In addition, I would suggest that these kinds of failures are “routine servicing” because they fall under “normal wear and tear”. (I would like to avoid the discussion of electronic parts that don’t have a wear-out failure mode.)
In my view, the practical intent of Part 806 is to keep FDA informed of device problems and fixes, not maintenance that doesn’t change the device. Many of the Warning Letters are “You sent a letter to your customers informing them of a problem that you intend to fix, but you didn’t inform FDA.”
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 15-Feb-2017 11:17
From: Peter Ohanian
Subject: Device servicing and Part 806
Thanks Dan. I appreciate the response. To clarify, are you indicating that corrective maintenance performed on a single device, lets say to replace a display that will not power on, should be evaluated for part 806 reportability? I agree that this is not "routine servicing" and is technically a correction. Do you think that this is what FDA really intended with part 806? I can understand if there is a trend of failures of this nature that a corrective action should be considered. However, do one-off device failures requiring corrective maintenance also require part 806 documentation? This is truly a game changer for equipment manufacturers!
BTW, I strongly endorse that every service event be evaluated for MDR reportability as well as complaint determination. Most corrective maintenance events are most likely also a complaint. From my experience, failure trends and need for potential field corrective action is best driven through the complaint and CAPA process.
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Peter Ohanian RAC
Principal Consultant
Halloran Consulting Group
Windham NH
United States
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Original Message:
Sent: 15-Feb-2017 10:28
From: Dan O'Leary
Subject: Device servicing and Part 806
There are a number of issues here, so let me break them out.
There are typically two kinds of maintenance – preventive and corrective. Corrective maintenance is not scheduled and is what I infer you mean by “unscheduled servicing”. Technically, under 806.2(d), this is a correction – a repair made at the equipment’s location.
The second question is whether the correction is reportable. Determine if the repair was made to reduce a risk to health or to remedy a violation of the act, see 806.10(a). If so then it is reportable unless it falls under one of the four exceptions: improve quality, market withdrawal, routine servicing, or stock recovery.
The third question is where to keep the records. All servicing records must be created and maintained following 820.200. If you don’t report under an exemption, create the records required by 806.20. The data elements in the two records are different, so you would need both.
Under 820.200(b), analyze the service records using appropriate statistical methodology in accordance with §820.100. If you find a high overall failure rate, then you have to remedy the problem. The replacements become reportable. They are not routine servicing and, because the device does not meet its performance requirements the failures are a violation of the act.
See the guidance document, Distinguishing Medical Device Recalls from Medical Device Enhancements.
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 14-Feb-2017 17:28
From: Peter Ohanian
Subject: Device servicing and Part 806
I am curious as to other's experience with this issue. In regard to many electro-mechanical devices or capital equipment, unscheduled servicing may be required to resolve a problem with a specific device. This servicing may involve replacement of a component or assembly. The service event affects only a single device in order to get the device operational. Would you consider this to be routine servicing (21CFR 806.2(k))? If not. would you evaluate each service event for 806 reportability? Would you report (or maintain the necessary documentation for) individual service events under part 806? Keep in mind that some products with a huge install base have thousands of service events each year. I am interested in your perspectives. Thanks in advance.
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Peter Ohanian RAC
Principal Consultant
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