Medmarc Insurance Group
Medical device manufacturers must ensure that they have a well-designed system to address complaints related to their products. Components of a well-designed system include: process/procedure, trained personnel, and proper record keeping.
A complaint 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 is released for distribution. The broad language concerning what constitutes an alleged “deficiency” means that manufacturers should be extremely cautious when determining what is and is not a complaint. It may be a good rule to treat any indication of dissatisfaction with a product as a complaint.
Manufacturers must be prepared to address not only complaints made directly to them, but also those they learn about from any source, including but not limited to reports and publications prepared by others.
The Food and Drug Administration (FDA) requires the manufacturer of a medical device to formally designate a unit within the company to oversee complaint handling. The personnel responsible for handling complaints should have the necessary background, education, training, and experience to handle their roles, including a thorough understanding of FDA complaint handling regulations. Training should be on-going and well-documented.
Written procedures for complaint handling will ensure that all complaints are reviewed in a timely and uniform manner. A complaint log or complaint file is required and should be updated whenever necessary. Basic information for the file includes but is not limited to the name of the device, date the complaint was received, complainant name and address, nature and details of the complaint, and the device identification/control number.
When reviewing a complaint, be sure to determine whether any additional investigation is necessary. Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications should be investigated further. Pay special attention to whether the complaint triggers any reporting requirements under FDA regulations. If the complaint triggers a Medical Device Report (MDR), ensure that the complaint file is clearly identified or maintained separately from other complaint files. (For additional information, please see the “Risk Management 101” on Medical Device Reporting.)
If an investigation is required, the basic information in the complaint file described above should be supplemented by including the dates and results of the investigation, any corrective action taken, and any communications to the complainant. Should the investigation trigger a need to make an MDR to the FDA, include information as to whether the device failed to meets its specifications, whether it was being used for treatment or diagnosis, and the relationship, if any, of the device to the reported incident or event.
When no investigation is made, maintain a record that describes the reason that no investigation was made and the name of the individual responsible for the decision not to investigate.
Complaint and investigation files must be maintained for a period equal to the expected life of the device, but in no case less than two years from the date the manufacturer releases the device for commercial distribution.
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