What QMSR Adds to ISO 13485 Complaint Records
A complaint procedure can follow ISO 13485 clause 8.2.2 closely and still miss something FDA asks for. In our experience the gap is rarely in the procedure. It is in the form.
Since February 2, 2026, 21 CFR Part 820 has been the Quality Management System Regulation, or QMSR. It incorporates ISO 13485:2016 by reference. It also adds a short section on records, 820.35, with its own text for complaints. If your complaint form was designed around the standard alone, this is the section to put next to it.
What the text says
Section 820.35(a) begins by saying that, in addition to clause 8.2.2 of ISO 13485, the manufacturer shall maintain records of the review, evaluation and investigation for any complaints involving the possible failure of a device, labeling or packaging to meet any of its specifications.
That wording is broad. It covers the device, its labeling and its packaging.
The data points
For three groups of complaints, the regulation lists information the manufacturer must record. The groups are complaints that must be reported to FDA under Part 803, complaints the manufacturer determines must be investigated, and complaints the manufacturer investigated regardless of those requirements.
For those complaints, the record must include:
The name of the device.
The date the complaint was received.
Any unique device identifier (UDI) or universal product code (UPC), and any other device identification.
The name, address and phone number of the complainant.
The nature and details of the complaint.
Any correction or corrective action taken.
Any reply to the complainant.
Pull up your complaint form. Check each field. It is common to find the first five and miss the last two, or to capture a complainant's name but not their address and phone number.
The "similar complaint" rule
The section also says that if an investigation has already been performed for a similar complaint, another investigation is not necessary. The manufacturer must then maintain records documenting the justification for not performing it.
This helps teams that receive many similar reports about the same issue. It is not permission to skip the paper. The written justification is the requirement. A sentence such as "duplicate of earlier complaint" may not tell a reader why the earlier investigation covers this case. A better note names the earlier complaint, says what makes the two similar, and says who made the call and when. That last part is recommended practice, not regulatory text.
Where it connects to other rules
Section 820.10(b) ties complaint handling to two other parts of the regulations. Under clause 8.2.3, the manufacturer must notify FDA of complaints that meet the reporting criteria of Part 803. Under clauses 7.2.3, 8.2.3 and 8.3.3, advisory notices are handled in accordance with Part 806.
This post does not decide whether any complaint is reportable. That is a judgment made against Part 803 itself, for each case. The point here is narrower. Your intake process should include a documented step where someone makes that decision and records it.
A ten-minute check
This part is recommended practice.
Pull your last ten closed complaints.
Lay your form beside the seven data points. Mark any field that is missing or often blank.
Look for any complaint closed as similar to another. Is the justification written down, and could a stranger follow it?
Check the "correction or corrective action" and "reply to the complainant" fields. If there was none, does the record say so, rather than leaving the field empty?
If a corrective action was taken, can you find the linked CAPA or change record from the complaint, and the reverse?
Most of the fixes are a form field and a line in the procedure.
A note on scope
Part 820 applies to manufacturers of finished devices. It does not apply to manufacturers of components or parts of finished devices, although FDA encourages them to consider it (820.1(a)). If you are unsure which category you fall into, settle that first.
This post is general education and does not guarantee compliance. Check the current regulation text for your own products.
If you would like a second pair of eyes on your complaint form or your wider system, Schedule a Readiness Conversation at qovaadvisory.com.
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