Medical Device Complaint Handling

Medical Device Complaint Handling. The manufacturer shall establish and maintain procedures for receiving, reviewing, investigating, and evaluating complaints relating to the quality, safety, or performance of medical devices, in accordance with 21 CFR 820.198 and the Quality System Regulation (QSR). A complaint 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. Each complaint shall be documented with: the date received, the name and contact information of the complainant, the device identification (model, lot/serial number), the nature of the complaint, the date and results of the investigation, any corrective action taken, and the date the complainant was notified of the resolution. Any complaint involving a death, serious injury, or malfunction that could cause or contribute to a death or serious injury shall be evaluated for Medical Device Report (MDR) filing obligations under 21 CFR Part 803. MDRs shall be submitted to the FDA within thirty (30) calendar days, or within five (5) days for events requiring remedial action to prevent an unreasonable risk of substantial harm to public health.