Regulatory Open Forum

Good Morning RAPS,

I am hopeful I can find some guidance from you on a hot topic we've been discussing. My organization has medical devices that have been on the market for almost 30 years. As our company has grown, so has the number of products we sell and our 'formally designated unit' / complaint team has seen complaint volume increase. Though our complaint rates have not increased, the number of reported complaints has tripled as our sales have tripled. It appears as if Part 820.198 (b) allows an option not to investigate a complaint. Does anyone have experience with this?

For example, we have been receiving the same complaint for about a year. When we first heard learned about the complaint, we opened a CAPA and investigated the issue with our engineering team and identified the root cause. We put a fix in place and made a product improvement to eliminate the failure. Being that we did this work a year ago, as we get the same kind of reported complaint, are there some options that might allow us to forgo a full investigation on these repeated events as they are called in? We understand that an evaluation of the complaint and a DHR review is necessary, but are there any other options that could save us administrative time? We also hold monthly trending meetings to review the complaint data and 'no investigation needed' would still be in this data.

820.198 Complaint Files

(b) Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate. 

Best Regards,

Haven

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Haven McCall, DRSc
Regulatory Affairs Professional
United States
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There are four things that trigger a mandatory complaint investigation:

Possible failure of a device to meet any of its specifications

Possible failure of labeling to meet any of its specifications

Possible failure of packaging to meet any of its specifications

Potentially reportable as an MDR

If the complaint is not one of the four, then investigation is optional. Be sure to document why you didn’t investigate.

If the complaint is one of the first three, then you must investigate, but you do not have to duplicate an investigation already conducted, see 820.198(c). The preamble, #190, says, “Section 820.198(c) then describes one subset of complaints that must be investigated, but explains that duplicative investigations are not necessary. In cases where an investigation would be duplicative, a reference to the original investigation is an acceptable justification for not conducting a second investigation.”

In the fourth case, you must always investigate. In addition, you would open an MDR Event File under Part 803 and record your decision to report or not.

On another note, you said, “We put a fix in place and made a product improvement to eliminate the failure.” You need to consider if your change is reportable under Part 806. If it improves the device quality but neither reduces a risk to health nor remedies a violation, then it would be exempt, 806.1(b)(1). Without the details, it appears you fixed a device problem that might be related to a performance specification. If so, this would remedy a violation so you would conduct a correction or removal and notify FDA. I recommend you review Part 806 and the guidance on distinguishing product enhancements from recalls.

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Dan O'Leary
Swanzey NH
United States

Original Message:
Sent: 04-24-2016 09:30
From: Haven McCall
Subject: Guidance on Not Investigating Routine Complaints

Good Morning RAPS,

I am hopeful I can find some guidance from you on a hot topic we've been discussing. My organization has medical devices that have been on the market for almost 30 years. As our company has grown, so has the number of products we sell and our 'formally designated unit' / complaint team has seen complaint volume increase. Though our complaint rates have not increased, the number of reported complaints has tripled as our sales have tripled. It appears as if Part 820.198 (b) allows an option not to investigate a complaint. Does anyone have experience with this?

For example, we have been receiving the same complaint for about a year. When we first heard learned about the complaint, we opened a CAPA and investigated the issue with our engineering team and identified the root cause. We put a fix in place and made a product improvement to eliminate the failure. Being that we did this work a year ago, as we get the same kind of reported complaint, are there some options that might allow us to forgo a full investigation on these repeated events as they are called in? We understand that an evaluation of the complaint and a DHR review is necessary, but are there any other options that could save us administrative time? We also hold monthly trending meetings to review the complaint data and 'no investigation needed' would still be in this data.

820.198 Complaint Files

(b) Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate. 

Best Regards,

Haven

------------------------------
Haven McCall, DRSc
Regulatory Affairs Professional
United States
------------------------------

Here’s an overview of the approach I’ve taken that has received FDA’s “gold star” in post-remediation FDA inspections:

1. Be sure that the nature and extent of the problem / failure mode is comprehensively understood and characterized during the inaugural complaint evaluation and investigation. (See Dan O’Leary’s excellent comments about when an investigation is required.)  In addition to Dan’s comments, I’d add that a full complaint investigation is also expected when problem recurrence is not tolerable based on risk.
2. If recurrence of the problem is not tolerable (based on risk), then investigation and corrective action (CA) are required.
3. Regardless of whether recurrence of the problem is tolerable (no CA needed) or intolerable (CA needed), establish corresponding data measurement/monitoring of the problem in order to keep tabs on its nature, scope, and frequency of occurrence.
4. During the post-implementation "incubation" period for a complaint’s CA, it is generally acceptable to cross-reference the inaugural complaint investigation (rather than performing a redundant investigation) while subsequent complaints involving the SAME problem continue to be lodged from the existing distribution pipeline.
5. Thereafter, diligent data measurement/monitoring must happen in order to assure two objectives:  a) determine whether or not CA (if any) sufficiently prevented or reduced recurrence of the problem.  b) detect if a tolerable problem’s nature, scope, and frequency have changed to something that is no longer tolerable.
6. If the CA isn’t effective, or if a heretofore tolerable problem becomes intolerable, then the aforementioned investigation is no longer valid and must consequently be supplemented or replaced.

Hope this helps,

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States

Copyright 2016 by ComplianceAcuity, Inc.

Original Message:
Sent: 04-24-2016 09:30
From: Haven McCall
Subject: Guidance on Not Investigating Routine Complaints

Good Morning RAPS,

I am hopeful I can find some guidance from you on a hot topic we've been discussing. My organization has medical devices that have been on the market for almost 30 years. As our company has grown, so has the number of products we sell and our 'formally designated unit' / complaint team has seen complaint volume increase. Though our complaint rates have not increased, the number of reported complaints has tripled as our sales have tripled. It appears as if Part 820.198 (b) allows an option not to investigate a complaint. Does anyone have experience with this?

For example, we have been receiving the same complaint for about a year. When we first heard learned about the complaint, we opened a CAPA and investigated the issue with our engineering team and identified the root cause. We put a fix in place and made a product improvement to eliminate the failure. Being that we did this work a year ago, as we get the same kind of reported complaint, are there some options that might allow us to forgo a full investigation on these repeated events as they are called in? We understand that an evaluation of the complaint and a DHR review is necessary, but are there any other options that could save us administrative time? We also hold monthly trending meetings to review the complaint data and 'no investigation needed' would still be in this data.

820.198 Complaint Files

(b) Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate. 

Best Regards,

Haven

------------------------------
Haven McCall, DRSc
Regulatory Affairs Professional
United States
------------------------------

If you have previously investigated the problem, and have performed, validated, and verified your corrective action, then you can reference the previous investigation in subsequent complaint files.  The product should still be returned for reasons below.

However, if you decide not to perform an investigation, you should have a process in place to verify that the subsequent complaints reported are the same failure.  Sometimes a similar, but new failure mode starts occurring and if the returned product is not checked for this, you will miss it.

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Christine Posin RAC
Consultant
Walnut CA
United States

Original Message:
Sent: 04-24-2016 18:52
From: Kevin Randall
Subject: Guidance on Not Investigating Routine Complaints

Here’s an overview of the approach I’ve taken that has received FDA’s “gold star” in post-remediation FDA inspections:

1. Be sure that the nature and extent of the problem / failure mode is comprehensively understood and characterized during the inaugural complaint evaluation and investigation. (See Dan O’Leary’s excellent comments about when an investigation is required.)  In addition to Dan’s comments, I’d add that a full complaint investigation is also expected when problem recurrence is not tolerable based on risk.


2. If recurrence of the problem is not tolerable (based on risk), then investigation and corrective action (CA) are required.


3. Regardless of whether recurrence of the problem is tolerable (no CA needed) or intolerable (CA needed), establish corresponding data measurement/monitoring of the problem in order to keep tabs on its nature, scope, and frequency of occurrence.


4. During the post-implementation "incubation" period for a complaint’s CA, it is generally acceptable to cross-reference the inaugural complaint investigation (rather than performing a redundant investigation) while subsequent complaints involving the SAME problem continue to be lodged from the existing distribution pipeline.


5. Thereafter, diligent data measurement/monitoring must happen in order to assure two objectives:  a) determine whether or not CA (if any) sufficiently prevented or reduced recurrence of the problem.  b) detect if a tolerable problem’s nature, scope, and frequency have changed to something that is no longer tolerable.


6. If the CA isn’t effective, or if a heretofore tolerable problem becomes intolerable, then the aforementioned investigation is no longer valid and must consequently be supplemented or replaced.

Hope this helps,

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States

Copyright 2016 by ComplianceAcuity, Inc.