FDA Part 820 Quality System Regulation - 820.198 Complaint files

Ajit Basrur

Staff member
Admin
#11
How would a contract manufacture handle a complaint for medical products in regards to the fact that the product is not shipped to the end customer but the designer of the product?
The contract manufacturer would only deal with the complaints from our customer the designer and not the end customer?
If the complaint is received by your customer, they will come to you for investigation of the manufacturing process that is done at your end.

The chain of complaint communication would be -

End customer to your Customer to you.
 
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R

rose24m03

#12
The contract that your company and your customer(s) signed should indicate your responsibility and theirs. For examples, if someone (designer or not) calls you to allege issues related to "identity, quality, durability, reliability, safety, effectiveness, or performance" (taken from 820.3(b) definition of a complaint), your customer should expect that you forward the information to them immediately so that they can evaluate the reported allegation against their complaint handling process.

Regardless who receives the allegations, if your customer needs you to investigate because you provided the part/product, then you would investigate and work with your customer, so that any reportable event could be reported within the required timeframe (i.e. MDR, vigilance report, corrections or removals). Ultimately, it's all about the safey of the patients, customers, users.

If complaints are not investigated and/or MDR/C&R are not filed by your customer (whoever put the device on the market), they get cited by the FDA and other regulatory agencies.

Your customer should have evaluated, approved and monitored you (contract manufacturer) per Purchasing Controls 820.50(a).

So, if your customer failed to implement complaint handling, MDR reporting, C&R reporting as required, with the addition of the root cause of the product poblems pointed to you (the contract manufacturer) in production and process controls issues, then your customer will get cited against 820.50 as well (for failure to control the contract manufacturer).

Hope this helps.


How would a contract manufacture handle a complaint for medical products in regards to the fact that the product is not shipped to the end customer but the designer of the product?
The contract manufacturer would only deal with the complaints from our customer the designer and not the end customer?
 
S

sfkevin

#13
Thanks for the details, I will make sure your information is past on to Management for the review of ISO 13485:2003.
:agree1:
 
R

rose24m03

#14
Silicon Valley has an ASQ location section. They have meetings or classes on medical device.

Bay area has a RAPS section as well. They just had a meeting this summer.

Clinivation has free web seminar on regulatory information.

AAMI has a 4-day class on FDA regulation first week of October with 2 1/2 hour optional exam on day 5.

There is always preamble to 21 CFR Part 820 on the FDA web site that you can navigate on what FDA expects.
 

Weiner Dog

Med Device Consultant
#15
Hi. I was an FDA investigator (level II certified international medical device investigator) for over 21 years and now a contract international medical device consultant.

Complaints are tricky. You have 2 paths follow-

1. Is it a "FDA defined" complaint?
2. If so, is the complaint an "MDR: complaint?
i. If so, is it a 5 or 30 day MDR complaint?

What I mean is:

1. First, you have to determine whether the complaint is one that fits the FDA definition: 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 is released for distribution (taken from 21 CFR 820.3(b)).

2. If so, then follow 21 CFR 820.198. However, there are time constraints. Not only conducting the complaint investigation and corrective action in a timely fashion, but also determining whether the complaint is an MDR complaint. This type of complaint is a high risk complaint- basically one that involves a death, serious injury, or malfunction.

You either have 5, (10), or 30 calendar days to report the MDR to the FDA:
a. 10 days if you are a user facility.
b. 30 days if you are an importer or manufacturer. But there is a caveat
with the manufacturer. 5 or 30 days, depending upon the situation.
c. 5 days for a manufacturer if the MDR is one which is:
(i) A reportable event that requires remedial action to prevent an
unreasonable risk of substantial harm to the public health, or
(ii) A reportable event for which FDA made a written request.

From 21 CFR 803.3, an MDR reportable event means:

(1) An event that user facilities become aware of that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or

(2) An event that manufacturers or importers become aware of that reasonably suggests that one of their marketed devices:

(i) May have caused or contributed to a death or serious injury, or

(ii) Has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Note:

Serious injury means an injury or illness that:

(1) Is life-threatening,

(2) Results in permanent impairment of a body function or permanent damage to a body structure, or

(3) Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Permanent means irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage.

AND

Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed.
 
R

Roland Cooke

#16
On a related note, when I audit I often ask how customer "whinges" are handled.

People tend to cope with easily-identified complaints fairly well, but the ways companies handle these less-clear-cut instances varies spectacularly, and is often poor.
 
A

auditnovice

#17
820.198 Complaint files

The requirement states in part, "Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 or 804 of PART 820 QUALITY SYSTEM REGULATIONS".

At what point does a Customer's call into a Service Department become a Complaint.

Does it only become a complaint if the issue being raised has caused Death, Serious Injury or the potential of Death, Serious Injury?

Or

If the Customer calls the Service Department for clarification or to schedule equipment repair or preventive maintenance, does this register as a complaint and if not does it have to be recorded?

:confused:
Having been an ex-FDA auditor, I think I can say that you have to draw the line between what is reportable as an MDR or not (with justification e.g., from medical professionals)..When I went into private industry, I developed a severity of harms chart for every high priority health/safety related event that could occur from the use of our products. We now use this as a baseline for determining if an "adverse event" is "reportable". This was a very labor intensive and cross functional activity. I don't know what your product is, as far as how your devices are classified by FDA.
Email me with more details and I'll give you better answers....I'm an expert at handling FDA complaints, let me know if you need any help....
 
Last edited by a moderator:

Wes Bucey

Quite Involved in Discussions
#18
Having been an ex-FDA auditor, I think I can say that you have to draw the line between what is reportable as an MDR or not (with justification e.g., from medical professionals)..When I went into private industry, I developed a severity of harms chart for every high priority health/safety related event that could occur from the use of our products. We now use this as a baseline for determining if an "adverse event" is "reportable". This was a very labor intensive and cross functional activity. I don't know what your product is, as far as how your devices are classified by FDA.
Email me with more details and I'll give you better answers....I'm an expert at handling FDA complaints, let me know if you need any help....
I appreciate your effort to help by supplying answers, but the nature of a PUBLIC forum is to keep the answers online and in the public domain for the benefit of others who may have similar problems.

There are times when it makes sense to "take it off-line" when there are situations where disclosure might raise a red flag at a customer, employer, or regulator.

I also understand the need for consultants, advisers, and other free-lance folk to "cast their bread upon the waters" by giving free advice in order to establish credibility and familiarity with the hope of getting paying business somewhere down the line, if not from the person initially helped by the free advice, then by someone who sees the extent, quality, and value of the advice given and says, "Hey! This might be the guy we need."

So, how far do we go in giving free advice before we we begin to feel like a sucker? Good question. My suggestion is for "consultants, advisers, and other free-lance folk" hoping to generate business to give good and complete general "text-book-type" answers in public, but sometimes add a disclaimer that
"often a client's specific circumstances require the services of a consultant who can take the time and effort for a fee to explore and help resolve a situation. I am such a consultant, as are others here on the Cove. You can contact me or any of those consultants via email or private message by clicking on the person's name at the top of a post to arrange a no obligation, confidential conversation about the scope of a prospective assignment and the fees involved."

Do I need to say that anyone who answers EVERY post with such a disclaimer is soon discounted and rarely considered for an assignment? People in public forums, especially here in the Cove, like to have a sense that the person posting answers is giving advice freely, not just as part of a guerilla marketing campaign. Nobody likes to deal with a salesman who is too pushy.
 
M

Metriculator

#19
Hi all,:bigwave:

As a new participant in this forum and the Medical Device field, I would like to say how much I appreciate everyone's participation and support.

I have the same question as the original poster, but I don't think it was answered.

I understand the MDR requirements. However, I am still confused as to what difference, if any, there is between a repair and a complaint.

Hypothetically, it appears that all product returned for repair would fall under the FDA definition of a complaint.

Is it possible that Repairs and Complaints may be distinguished with regard to the amount of time in use, (within the 1 year warranty period vs. 8 years beyond the warranty).

Any additional comments would be welcomed.

thanks, Marc
 

Weiner Dog

Med Device Consultant
#20
Hi all,:bigwave:

As a new participant in this forum and the Medical Device field, I would like to say how much I appreciate everyone's participation and support.

I have the same question as the original poster, but I don't think it was answered.

I understand the MDR requirements. However, I am still confused as to what difference, if any, there is between a repair and a complaint.

Hypothetically, it appears that all product returned for repair would fall under the FDA definition of a complaint.

Is it possible that Repairs and Complaints may be distinguished with regard to the amount of time in use, (within the 1 year warranty period vs. 8 years beyond the warranty).

Any additional comments would be welcomed.

thanks, Marc
Marc-

Not all repairs or services (i.e. under 21 CFR 820.200) would fall under the definition of a complaint (or 21 CFR 803 MDR). The key is whether the repair is related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device. It also depends whether the repair or service is typical for the device (i.e. "routine" which is usually noted in the product labeling/warranty). If it is a routine repair or service, then it may not be a complaint. However, if the repair or service changes any predetermined specification, then design controls also comes into play. ;)
 
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