If you manufacture medical devices, you must follow strict rules for handling complaints. These rules are explained in 21 CFR Part 820.198, which is part of the FDA’s Quality System Regulation (QSR). Failing to meet these requirements can result in serious legal action, including warning letters, fines, or even product recalls.
This article breaks down what you need to document and why it matters.
What Is a Complaint?
According to the FDA, a complaint is any written, electronic, or oral communication that claims a device is not working as expected. This includes:
- Product defects
- Device failures
- Safety concerns
- Labeling mistakes
- Performance problems
Even a phone call reporting a malfunction counts as a complaint. If someone claims the device may have caused harm, the complaint becomes more serious and may need to be reported under MDR (Medical Device Reporting) rules.
Basic Documentation Required
The first thing you must do is record the complaint. Every complaint must go into a complaint file. Each entry must include:
- Name of the complainant
- Device name and model number
- Date of the complaint
- Description of the issue
- Any follow-up communication
Keep all documents in one place, whether physical or digital. The FDA may ask to review them during an inspection.
When Is an Investigation Required?
Not all complaints require a full investigation. But you must always:
- Review the complaint to decide if it needs investigation
- Record that decision
- Document why the investigation is or is not needed
If the issue could relate to device failure, serious injury, or death, you must investigate.
Also, if you have seen the same problem in other complaints, you should consider a full investigation to find the root cause.
What Should an Investigation Include?
If you decide to investigate, your documentation must include:
- What steps you took during the investigation
- What you found
- Any testing or inspection results
- Who did the investigation
- When it was completed
You also need to describe what actions, if any, were taken to correct the issue or prevent it from happening again.
Determining If MDR Applies
The FDA wants to know if complaints may be serious enough to need Medical Device Reporting (MDR).
You must document:
- Whether the issue caused or could cause serious injury or death
- Whether the issue has happened before
- Whether the device was used correctly at the time
If the answer is yes, you may need to submit a report to the FDA within a specific time limit, usually within 30 calendar days of becoming aware of the issue.
If no MDR is needed, you still need to write that down, along with why.
Complaint Trends and Risk Analysis
You must not treat each complaint as a one-time event. If multiple complaints are similar, you may be facing a systemic issue.
Your documentation should:
- Track similar complaints over time
- Identify patterns or trends
- Show any risk assessment you performed
- Record any changes made to the design, labeling, or manufacturing process
This information can also help during management reviews and internal audits.
Who Should Handle Complaints?
The regulation says that only people trained and qualified to evaluate complaints should do so. This usually means:
- Quality assurance staff
- Regulatory affairs specialists
- Engineers
- Medical professionals (for clinical complaints)
The name of the person doing the review and their signature or digital approval must be part of the file.
Complaint Files Must Be Available
During an FDA inspection, investigators may ask to see your complaint files. These files must be:
- Readily available
- Complete and organized
- Protected from unauthorized editing
Even if you use an electronic system, it must have date stamps and access control.
If your complaint handling is outsourced to a third party (like a distributor), you are still responsible for keeping records that meet FDA standards.
How Long to Keep Complaint Records
According to FDA rules, you must keep complaint records for at least 2 years from the date the complaint was received or as long as the device is in use, whichever is longer.
This timeline helps the FDA follow up if the issue becomes part of a larger safety concern.
What Happens If You Don’t Comply?
Poor complaint handling can lead to serious problems, such as:
- FDA warning letters
- Product recalls
- Consent decrees
- Loss of customer trust
Many FDA warning letters specifically mention missing complaint files, lack of investigation, or failure to assess MDR reporting.
Best Practices for Strong Documentation
To stay compliant with 21 CFR 820.198, here are some tips:
- Use a standard form to document each complaint
- Have a clear decision tree for when to investigate
- Include checklists for MDR decisions
- Use software that tracks complaint status and deadlines
- Train your team regularly on complaint procedures
Consistency is key. The FDA looks not just at your forms but also at how well your system works across departments.
Difference Between Service Records and Complaint Files
Sometimes issues are found during routine service or maintenance. If the problem matches the definition of a complaint, it must be logged as such, even if the customer didn’t complain directly.
You must separate service records from complaint files, but both must be reviewed for possible safety concerns.
Integrating Complaints Into Your Quality System
Complaint data should not sit alone. It must feed into your:
- CAPA (Corrective and Preventive Action) system
- Internal audits
- Design changes
- Supplier reviews
The complaint file is a starting point, not an ending. If a problem is real and recurring, it must lead to action
Final Thoughts
Handling complaints the right way isn’t just about checking boxes, it’s about keeping patients safe and improving your product. Under 21 CFR Part 820.198, your complaint files must clearly show:
- What was reported
- What decisions were made
- What actions were taken
Good documentation not only keeps you in line with the FDA, but it also helps your team fix problems faster and make better products.
By following clear steps and keeping solid records, you stay audit-ready and protect your business from risk.