It is absolutely essential to establish a robust and effective complaint handling systems for device-related reportable events in compliance with 21 CFR 803. However, the trending of such reportable device complaints is also explicitly required under 21 CFR 820.100, and often overlooked by Regulatory compliance professionals.


Sec. 820.100 Corrective and preventive action

(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:

(1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;

Establishing a statistical method to analyze/trend device complaints and other key Quality indicator will be instrumental in maintaining Quality Management of the product, as well as compliance with regulatory requirements.