21 CFR Part 803 compliance

Complaints handling mistakes, medical device reporting, and CAPA are the most common reasons for FDA 483 inspection observations, but why?

Reasons for FDA 483s related to the CAPA process

You should already be well aware that deficiencies in the CAPA process, complaints handling, and medical device reporting are the three most common reasons why the FDA issues 483 inspection observations and Warning Letters in 2023. The most common reason for an FDA 483 inspection observation is related to the CAPA process (i.e., 336 observations citing 21 CFR 820.100). For the CAPA process, all 336 observations cited problems with inadequate procedures or inadequate records.

Reasons for complaints handling mistakes

The complaints handling process is the second most common reason for FDA 483 inspection observations (i.e., 276 observations citing 21 CFR 820.198). The complaints handling process has nine different reasons for 483 inspection observations (listed from most common to least common):

1. Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established.  Specifically,*** 
2. Complaints involving the possible failure of [a device] [labeling] [packaging] to meet any of its specifications were not [reviewed] [evaluated] [investigated] where necessary. Specifically, *** 
3. Records of complaint investigations do not include required information.  Specifically, *** 
4. Complaint files are not [adequately] maintained.  Specifically, *** 
5. Not all complaints have been [adequately] reviewed and evaluated to determine whether an investigation is necessary. Specifically, ***
6. Records for complaints where no investigation was made do not include required information.  Specifically, *** 
7. Complaints representing events that are MDR reportable were not [promptly reviewed, evaluated, and investigated by a designated individual] [maintained in a separate portion of the complaint files] [clearly identified]. Specifically, ***
8. Investigation records of MDR reportable complaints do not include required information.  Specifically, *** 
9. Records of complaint investigations do not include required information, including any unique device identifier (UDI) or universal product code (UPC).  Specifically, ***

Reasons for FDA 483s related to Medical Device Reporting

There were 106 observations related to medical device reporting (i.e., 21 CFR 803) in 2023 thus far. There are 25 different reasons identified by the FDA for 483 inspection observations related to the Medical Device Reporting regulation. The majority o of the inspection observations were related to an inadequate or missing MDR procedure. However, there were also a number of inspection observations that were related to missing information in the MDR records. Therefore, we updated our Medical Device Reporting Procedure to include all of the required elements of the FDA’s MedWatch Form. We posted a blog about “Where to Focus your Medical Device Complaint Handling Training.” In that blog we answered questions from device manufacturers and consultants regarding the process of complaints handling investigation. The following section is a summary of my responses to those questions.

Complaints handling investigations

What criteria do you think should be used to determine whether a complaint should be investigated or not?

There is only one acceptable rationale for not investigating a complaint. If you don’t investigate complaints when required, then you might receive an FDA Form 483 observation worded like this…

21 CFR 820.198(c) – Complaints involving the possible failure of labeling to meet any of its specifications were not investigated where necessary. Specifically, a missing IFU was reported in customer complaints, but no investigation was conducted. The rationale documented in the complaint record was “the missing IFU presented no patient risk.”

A missing IFU is a “failure of labeling to meet any of its specifications.” Therefore, 21 CFR 820.198(c) requires you to conduct an investigation “unless such investigation has already been performed for a similar complaint, and another investigation is not necessary.” This is the only rationale that is acceptable for skipping your investigation. To ensure that no one forgets to investigate a complaint, make sure you include a space in your complaint handling form that is specifically labeled as “Summary of Complaint Investigation.” This space should also include an option to cross-reference to a previous complaint record where a similar investigation is already documented.

A missing IFU is also considered a misbranded product that requires correction (e.g., sending the customer a replacement IFU) or removal (i.e., recall). The FDA expects a Health and Hazard Evaluation (HHE) form to be included in your recall records, and the HHE should indicate the potential risk of a “delay in treatment.” This is the FDA’s conclusion in their evaluation of risk, and therefore your HHE must identify a delay in treatment as a patient risk too. The FDA also expects a CAPA to be initiated to prevent the recurrence of this type of labeling error. You can make a “risk-based” determination that reporting a specific recall to the FDA is not required as per 21 CFR 806.20. However, you need to maintain records of your determination not to report a recall. If you already received a Warning Letter, you should err on the side of reporting anyway.

Note: References to “recall” in the above paragraph are meant to include field corrections.

Intended Use

If a complaint consists of a medical device being used for something other than its intended use, is an MDR required for this user error?

The answer is yes. If you don’t report adverse events involving “user error,” then you might receive an FDA Form 483 observation worded like this…

21 CFR 803.17(a)(1) – The written MDR procedure does not include an internal system which provides for the timely and effective evaluation of events that may be subject to medical device reporting requirements.  Specifically, several incidents where a death or serious injury occurred were “caused by a user error,” and the procedure did not identify this as an event requiring Medical Device Reporting.

In 21 CFR 803.3, the FDA defines “caused or contributed” to include events occurring as a result of:

1. Failure
2. Malfunction
3. Improper or inadequate design
4. Manufacture
5. Labeling, or
6. User error

It is important to understand that the definition of complaints and the requirement to report adverse events should not be “risk-based.” The need for remediation and the need to report corrections and removals can be “risk-based,” but whether something is a complaint, and whether it is reportable should be “black-and-white.” For example, “Did the death or serious injury occur due to a ‘user error’-including use other than the intended use?” If the answer is yes, then it is a complaint and reportable.

Incidents and Adverse Event Reporting

Do incidents that occurred outside the United States need to be reported to FDA?

The answer is yes. If you don’t report adverse events that occur outside the United States, then you might receive an FDA Form 483 observation worded like this…

21 CFR 820.50(a)(1) – An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused, or contributed to, a death or severe injury. Specifically, several instances were identified where the device caused or contributed to a death or serious injury, and the event was not reported to the Agency. The rationale documented in the complaint record was that the “event occurred outside the United States.”

This type of mistake is most likely due to a lack of training on 21 CFR 803–Medical Device Reporting. Some manufacturers that distribute products internationally are more familiar with the European Vigilance requirements as defined in Articles 87-89 of Regulation (EU) 2017/745. You can find additional guidance on vigilance reporting in our Vigilance Procedure or the applicable MDCG guidance. The European Medical Device Directive (i.e., MDD) only required vigilance reporting of incidents that occurred outside the Member States of the European Economic Area (EEA), Switzerland, and Turkey if the incident required implementation of field safety corrective actions. The EU MDR now requires reporting of incidents that occur outside of the EU if the device is also made available in the EU.

The FDA Part 803 requirements are worded differently. Part 803 does not indicate that the event had to occur in the United States. The MedWatch form (i.e., FDA Form 3500A) must be filed for events that occur in the United States and events occurring outside the USA if the devices are “similar” to devices marketed in the USA. Unfortunately, most device manufacturers are not aware of this requirement. Therefore, the FDA released a final guidance on Medical Device Reporting requirements on November 8, 2016. If you would like to learn more about Medical Device Reporting requirements, you can purchase our MDR procedure and webinar bundle. We will also be expanding our consulting services in January 2024 to include Medical Device Reporting for our clients.

Additional Resources on Complaints Handling

Medical Device Academy sells a complaints handling procedure, and a webinar on complaints handling. We will be updating the procedure during the holidays and hosting a new live complaints handling webinar on January 4, 2024. If you purchase the webinar, or you purchased the webinar in the past, you will receive an invitation to participate in the live webinar in January. If you purchase the complaints handling procedure, or you purchased the procedure in the past, you will receive the updated procedure, updated complaints handling form, and updated complaints log. You will also receive an invitation to the live webinar because we will be bundling the webinar with an updated procedure. We will also provide a discount code during the live webinar for people to upgrade their purchase of the webinar to include the purchase of the procedure. Customers who purchased one of our turnkey quality systems will also receive access to the live webinar.