21 CFR 820.198 - Complaint Files (QMSR)

What it says

Manufacturers must maintain complaint files and establish procedures for receiving, reviewing and evaluating complaints, with formally designated units responsible for processing complaints, and any complaint representing a possible failure of a device to meet its specifications must be reviewed and evaluated to determine whether an investigation is necessary.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This provision mirrors 21 CFR 211.198 for drugs closely in structure, requiring documented review of every complaint alleging possible product failure and a documented determination on whether investigation is warranted.
• For devices specifically, certain complaints also carry separate Medical Device Reporting obligations, meaning a single complaint can trigger both an internal complaint investigation and an external regulatory reporting obligation on separate but related timelines.
• A designated complaint-handling unit or function is an explicit organisational expectation, similar in spirit to the quality unit review requirement for drug complaints.

What FDA inspectors look for

• Whether every complaint alleging a possible device failure receives documented review and a clear determination on investigation, mirroring the same standard applied to drug complaints.
• Whether complaints that meet Medical Device Reporting criteria are correctly identified and reported within the applicable regulatory timeline, separate from the internal complaint investigation itself.
• Whether complaint trend data is reviewed collectively, feeding into the broader CAPA system rather than being assessed only complaint by complaint.

Related regulations