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 Complaint Files

Slide 1 

Hello, my name is Stanley Liu, and I’m a Consumer Safety Officer in the Division of Industry and 

Consumer Education. I worked in industry for many years, and know how difficult it is to compete and 

manufacture medical devices in the United States. Working at FDA, I also understand the “big picture” 

regulatory framework that helps ensure quality. I hope to bring a balanced picture from both perspectives 

to my discussion today on Complaint Files.

Slide 2

Complaint Files are a key, but often neglected, aspect of the Quality System for medical device 

manufacture. It’s human nature to focus on getting a task accomplished, in this case, getting a device 

marketed and manufactured. But what comes afterwards is oftentimes forgotten or neglected. However, 

what occurs after a device is released for distribution can be just as important as premarket and 

manufacturing activities. When Complaint Files are properly handled and coupled with other corrective 

action systems, the result is a mechanism that can be used to learn from past mistakes. This can result in 

successful product longevity, increased market share, and consumers will ultimately benefit from a better, 

safer, and more effective product.

Slide 3

Today, I will be focusing on the following three Learning Objectives: One - Understand the context of 

Complaint Files within the overall Quality System and Corrective and Preventive Action, or CAPA, 

subsystem. Two - Learn about the mechanisms of Complaint Files and their continual Postmarket role, 

and Three - Understand the contribution of Complaint Files to Quality and Safety. These three key 

objectives will give you a firm start in understanding the role, function, and importance of Complaint Files.

Slide 4

What is the CAPA subsystem? It’s a key component of the Quality System, and is itself comprised of 

three parts. This is articulated in this simplified and generalized table – Nonconforming Product, which 

functions primarily during Manufacturing; CAPA, which functions during both Manufacturing and After 

Distribution; and Complaint Files, which generally functions After Distribution. I’ll be focusing today on 

Complaint Files, as highlighted in bold.

Slide 5

Complaint Files, in turn, comprise seven sections, labeled “a” through “g,” as listed here. However, you 

can think of them as being divided into “procedural mechanisms” – “a” through “d,” and “record-keeping 

requirements” – “”e” through “g.” We will go through each of these groups in greater detail as I progress 

through my discussion.

Slide 6

Now that we’ve taken a brief look at how Complaint Files are laid out, let’s explore the procedural 

mechanisms. We’ll start with the formal definition of a Complaint. What is a Complaint? It is any written, 

electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, 

reliability, safety, effectiveness, or performance of a device after it’s released for Distribution. In other 

words, a Complaint is any communication alleging an issue with a device after it’s been released for 

Marketing and Distribution.
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Slide 7

All complaints must be processed in a specific manner, as defined in the first Complaint Files subsection, 

General Requirements. Manufacturers must Establish and Maintain procedures for receiving, reviewing, 

and evaluating complaints by a Formally Designated Unit. This Unit must ensure: processing of 

complaints in a uniform and timely manner; documentation of oral complaints upon receipt; and 

evaluation to determine if a Failure Investigation and/or a Medical Device Report, or MDR, is required.

Slide 8

Some devices may require servicing after distribution. And during this servicing, complaints may arise. 

What do you do with servicing reports with potential complaints? Well, there are many different solutions, 

and I will describe two common ones. First, manufacturers may train servicing personnel to identify

possible complaints and flag them for the formally designated unit to subsequently review. Second, 

manufacturers may have the formally designated unit itself review all servicing reports and records for 

possible complaints. Each solution has its advantages and disadvantages. Manufacturers have the 

freedom to find a solution that meets both the regulatory requirements as well as their own needs. 

Please note that these examples focus solely on Servicing as they relate to Complaint Files, and we won’t 

be discussing Servicing beyond this limited scope.

Slide 9

Once an alleged complaint has been received, manufacturers must review and evaluate complaints to 

determine if an investigation is necessary. If you determined that an investigation isn’t required, then 

accountability information such as the reason and responsible individual must be documented.

Slide 10

Any alleged complaint involving the possible Failure of a device and/or its labeling and packaging to meet 

specifications must be Reviewed, Evaluated, and Investigated. The exception to this would be when an 

investigation has already been performed on a similar complaint. Please note, though, that a similar 

complaint may not require an investigation under Complaint Files, but it may require a Corrective and 

Preventive Action investigation due to recurrence. I’ll discuss CAPA referrals later in this presentation.

Slide 11

Let’s briefly discuss a specialized form of complaint known as a Medical Device Report or MDR. All

MDRs are a form of complaint; however, not all complaints are MDRs. Our discussion will focus strictly 

on MDRs within the context of Complaint Files. When MDRs are received, they must be promptly 

reviewed, evaluated, and investigated by designated individuals, just like complaints. However, MDRs 

must also be maintained in a separate part of the Complaint Files or be otherwise clearly identified. 

Additionally, investigation records must be kept indicating: whether the device failed specifications; any 

use in treatment/diagnosis; and the relationship of the device to the reported incident. Additional 

information on MDRs can be found in 21 Code of Federal Regulation, CFR, 803.

Slide 12

Now, let’s look at a very basic, simplified diagram of how the three CAPA subsystems function, focusing 

on After Distribution mechanisms on the right. Corrective and Preventive Action is in the middle, spanning 

both Manufacturing and After Distribution. Complaint Files and Medical Device Reporting are in the lower 

and upper right, respectively, within After Distribution. Complaints enter from the lower right.

Note that complaints initially go to Complaint Files. From this point, they may be handled locally, or 

referred to CAPA. MDR Complaints are fed into the MDR system, which can also potentially lead to 

CAPA.
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Slide 13

With a basic understanding of how a Complaint Files System is established and maintained to review, 

evaluate, and investigate Failures and MDRs, I’ll now turn my focus to two common questions that are 

asked of the FDA. The first is, “Why are Investigations necessary?” Isn’t it enough to simply catalog and 

note complaints and failures? The answer is, “no.” Based on statistical probability, the likelihood that a 

product line will eventually have a Failure or MDR increases as time passes. Such a Failure can 

conceivably impact everything from manufacturing to design. A robust investigative system ensures 

responses/reactions are: accurate, appropriate, and timely. Complaints are captured, reviewed, 

evaluated, investigated, and corrections made. The end result is a better, safer, and more effective 

product.

Slide 14

The second common question is, “Why are there no specifics on how to conduct an Investigation?” On 

first glance, the Regulation does not appear to be that complicated or specific. There are a multitude of 

variables and reasons for this. These include: the heterogeneous nature of devices and complaints; 

risks involved; severity of issues; frequency of complaints; and many other factors, including conditions 

and context. Therefore, a set of prescriptive requirements governing all possible variables and situations 

is simply not feasible. Consequently, the Regulation is flexible.

Slide 15

The FDA recognizes that it cannot foresee every potential situation or contingency. As a result, the 

Regulation is not vague; rather, FDA has given manufacturers the freedom to define their own

circumstances. Manufacturers must understand their own product, associated risks, the conditions and 

context for use, and apply the regulatory requirements to make their own Complaint Files System work.

The result is that manufacturers must decide upon their own details.

Slide 16

Manufacturers are responsible for the details of their own Compliant File system. These would include: 

Definitions, Actions, and Investigation Thresholds. For Definitions, this means defining Failures of devices 

and labeling/packaging, MDRs, and “other” or “non-complaint” communications. For Actions, the 

manufacturer must establish criteria for what constitutes an Investigation, as well as what happens with 

“other” activities such as “non-complaints” and similar complaints. Finally, there needs to be provision for 

Investigation Thresholds, specifically, when should complaints be handled locally under Complaint Files 

or referred to CAPA. This last topic – Thresholds - is something we’ll now examine in more detail.

Slide 17

Corrections should be handled locally under Complaint Files if they meet the following general criteria: 

easy/specific correction; isolated incident, minor issue; not a design issue; and not a Manufacturing issue.

I have provided illustrative examples in the next 5 slides.

Slide 18

Easy/specific correction - a device was mishandled during shipping and is dented or scratched.

Slide 19

Isolated incident - a minor malfunction occurred when it was used once outside the intended/indicated 

uses in an unanticipated way.
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Slide 20

Minor issue - a part became loose or unattached but was not damaged.

Slide 21

Not a design issue - the plastic casing cracked when accidently dropped.

Slide 22

Not a Manufacturing issue - the Instruction Manual got lost during unpacking.

Slide 23

Complaints should be referred to CAPA if they meet the following general criteria: no easy/specific 

correction; recurring problem; severe issue; a design issue; and a Manufacturing issue. Again, I have 

provided illustrative examples in the next 5 slides.

Slide 24

No easy/specific correction - complaints of short battery life.

Slide 25

Recurring problem – a large amount of product frequently dented or scratched during shipping over time.

Slide 26

Severe issue – a device caught on fire or exploded. 

Slide 27

Design issue - reports of frequent, specific malfunctions in a high E.M. area.

Slide 28

Manufacturing issue - mold was found inside packaging.

Slide 29

In deciding on specific threshold parameters, balance is key. Too many failures handled under 

Complaints may fail to address systemic issues. Generally, Complaint File issues should be simple, 

specific, and contained. Conversely, too many complaints referred to CAPA will overwhelm that system. 

Generally, CAPA handles more complex, ambiguous, and systemic issues. I hope my previous examples 

help to illustrate the general type of line that needs to be drawn.

Slide 30

Now let’s view a final assembled diagram of how Complaint File investigations work. Note that this is 

again simplified for illustrative purposes. Complaint Files are in the center, while Corrective and 

Preventive Action and Medical Device Reports are in the upper and lower right side, respectively. 

Complaints enter from the left side. An initial complaint is received, reviewed, and evaluated. If it is not a 

complaint, then it is either closed or dealt with in another manner. If the complaint requires further 

investigation, as in the case of device failures, then it proceeds to the investigation phase. MDRs are 

identified or separated and dealt with separately, which may include forwarding to CAPA. Failure 

investigations are examined to determine whether they are to be handled within the Complaint Files 

system or referred to CAPA for further action.
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Slide 31

Now that we’ve examined the basic procedural mechanism for the Complaint Files System, let’s switch 

gears to focus on the second part of the Regulation regarding Complaint Files, record keeping for the 

actions that we’ve discussed. Complaint File Records must be maintained to capture: the device name; 

date the complaint was received; unique device identifiers; complainant contact information; nature or 

details of the Complaint; results and dates of the investigation; Corrective Action taken; and the response 

to the Complainant.

Slide 32

In cases where a designated complaint unit is located off-site, and/or outside of the U.S., records must be 

reasonably accessible to the manufacturer and the FDA at either the U.S. location where the records are 

regularly maintained, or with the initial distributor or importer. Such records must comply with all other 

Quality System Records requirements as per 21 CFR 820, Subpart M.

Slide 33

Additional information on the Quality System, its Preamble, and the FDA Inspection Guide can be found 

at the links on this slide.

Slide 34

In concluding this presentation, I now ask you to take on the following Call to Action:

Use your Complaint File system to learn from mistakes, they can impact everything from quality to design 

to manufacturing. Know that Complaint Files are a gateway mechanism for CAPA and postmarket 

activities. And leveraging a robust Complaint File system, to avoid repeating mistakes, can allow you to 

improve the quality and safety of your product.

Slide 35

We encourage you to use other industry education resources we've developed especially for you, as 

shown on this slide. Of note, for comprehensive regulatory information, please contact CDRH’s Division 

of Industry and Consumer Education. We look forward to helping you.

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