820.198 Complaint files.

(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:

(1) All complaints are processed in a uniform and timely manner;

(2) Oral complaints are documented upon receipt; and

(3) Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 or 804 of this chapter, Medical Device Reporting.

Interpretation:

We can not do justice explaining this subject here.  However, note that the FDA is ever increasing it’s examination of manufacturers complaint handling system.  You can put your money on the reality that the FDA will ask to see your complaint handling procedure and will inspect a sample (or all) of the complaints for (but not limited to) a whole year. 

The one problem many firms have is the requirement to document oral complaints.  If you have person (secretary, administration assistant, etc) answering the phone (first line of contact between the customer) you should ensure that this person has been trained to recognize and document complaints, and that this list is soon afterwards evaluated (by quality department) for ‘reportable’ events.

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Reference: www.FDA.gov

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