(a) Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that:
- All complaints are processed in a uniform and timely manner;
- Oral complaints are documented upon receipt; and
- Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Reporting.(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.(c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.(d) Any complaint that represents an event which must be reported to FDA under part 803 of this chapter shall be promptly reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint files or otherwise clearly identified. In addition to the information required by 820.198(e), records of investigation under this paragraph shall include a determination of:
- Whether the device failed to meet specifications;
- Whether the device was being used for treatment or diagnosis; and
- The relationship, if any, of the device to the reported incident or adverse event.(e) When an investigation is made under this section, a record of the investigation shall be maintained by the formally designated unit identified in paragraph (a) of this section. The record of investigation shall include:
- The name of the device;
- The date the complaint was received;
- Any device identification(s) and control number(s) used;
- The name, address, and phone number of the complainant;
- The nature and details of the complaint;
- The dates and results of the investigation;
- Any corrective action taken; and
- Any reply to the complainant.(f) When the manufacturer’s formally designated complaint unit is located at a site separate from the manufacturing establishment, the investigated complaint(s) and the record(s) of investigation shall be reasonably accessible to the manufacturing establishment.(g) If a manufacturer’s formally designated complaint unit is located outside of the United States, records required by this section shall be reasonably accessible in the United States at either:
- A location in the United States where the manufacturer’s records are regularly kept; or
- The location of the initial distributor.
If you choose to do so, you can make one cohesive complaint management SOP that covers all bases. However, as your organization progresses into multiple markets, the requirements will start to multiply, as well. The doctor is not going to waste the time of the readers by reviewing all of the tiny nuances needing to be addressed in a SOP. You can purchase Devine Guidance for Complying with the FDA’s QSR from Amazon.com. However, Dr. D is going to address the salient requirements that a complaint management procedure needs to encompass.
Regardless of how benign a customer complaint might appear to be, it needs to be reported. For example, if a physician puts an itsy-bitsy-teeny-weeny hole in a surgical glove because of a sharp edge on a catheter handle, that is a complaint. Is it going to be an MDR, probably not? If a device fails to work out of the box it is going to be a complaint. Is it going to be an MDR, probably not? If a member of your sales team is reading a medical journal and stumbles upon an article that “disparages” (look-it-up) on of your organization’s medical devices, that my friends is a reportable complaint. Is it going to be an MDR? It depends and Dr. D is not talking about adult diapers. The need to report will be premised on the outcome of the investigation.
- Collecting basic complaint information (read §820.198 for specifics);
- Recovering the device that the complaint is premised on;
- Decontaminating the device, if it has been used;
- Performing a thorough root cause investigation;
- Employing a decision tree to determine if the complaint is reportable as and MDR in the United States (reference Part 803); a vigilance report in the EU (reference MEDDEV 2.12-1); or reportable elsewhere;
- If deemed necessary and appropriate, opening a Corrective Action in the CAPA System to address and correct the complaint;
- Making sure all complaints are reviewed and approved by a person with a clinical/medical background (note: should be a physician, nurse practitioner, or registered nurse); and
- Sending a follow-up letter to the complainant, if one is requested (a well-worded professional response always a nice gesture).
One – if you receive a complaint, consider it valuable feedback from your customer. They are reaching out to your organization.Two – always perform an in-depth failure investigation.Three – not all complaints are required to be reported as MDRs; however, you better make sure that the complaints that rate as MDRs are reported.Four – ensure an individual with a clinical/medical background reviews and approves all complaints.Five – if your organization fails to correct the issues associated with a complaint, trust the doctor when I say; “Your competition will gladly help your customers move their business!”
- Code of Federal Regulation. (2013, April). Title 21 Part 803: Medical device reporting. Washington, D.C.: U. S. Government Printing Office.
- Code of Federal Regulation. (2013, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- MEDDEV 2.12-1, Revision 7. (2012, March). Guidelines on a medical device vigilance system. Retrieved September 26, 2013, from http://www.obelis.net/docs/Guidelines_MEDDEV_212-1_rev7_march_2012.pdf