Complaint management systems are a necessary part of a Quality Management System. Complaint management is defined as 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. As outlined in 21 CFR 820.198, each manufacturer maintains complaint files and has a process for receiving, reviewing, and evaluating complaints. This must be done in a timely manner and be done by a formal complaint handling unit. Once the complaint is received, the manufacturer will determine whether an investigation is necessary. Investigations will be necessary if a complaint is received involving the failure of a device, label, or package to meet its specifications unless one has already been performed for a similar complaint.
When an investigation is made, a record must be kept by the formal designated unit which includes the following information:
- The name of the device and any unique device identifiers
- A timeline of when the complaint was received and when the investigation was opened.
- Information from the complainant including name, address, phone number, and what the complaint was opened for.
- Results of any investigation that was performed and any CAPA’s established as a result.
- Any reply to the complainant
When a complaint is received that represents an event that must be reported to the FDA (21 CFR 803), it shall be kept in a separate location. Investigations associated with these complaints need to also state whether the device failed to meet specifications, whether the device was being used for treatment or diagnosis, and any relationship of the device to the reported incident or adverse event (United States Food and Drug Administration, 2023).
If you need support in understanding 21 CFR 820.198 or developing a complaint management system that is compliant with FDA regulations, the experts at EMMA International can help! Call us at 248-987-4497 or email us at info@emmainternational.com to learn more.
United States Food and Drug Administration. (2023, Janruary 17). CFR – Code of Federal Regulations Title 21. 8. Retrieved April 17, 2023, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=820.198
