Complaints

The term Complaint, as it relates to medical devices, refers to any formal communication alleging a deficiency related to a device after it has been released for distribution. The handling of complaints is a mandatory and critical process within a medical device manufacturer’s Quality Management System (QMS).

In simple terms, a Complaint is an allegation that something went wrong with the device's design, quality, or performance after it left the factory, and it triggers a legal obligation for the manufacturer to investigate and report.

Definition and Scope of a Complaint

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.

For certain products, such as human cells, tissues, and cellular and tissue-based products (HCT/P), a complaint specifically means any communication alleging that the product has transmitted or may have transmitted a communicable disease to the recipient, or any other problem relating to the potential for communicable disease transmission.

Complaint Management System Requirements

Manufacturers must establish and maintain complaint files. The FDA's Quality System Regulation (QSR, 21 CFR 820) requires manufacturers to establish and maintain formal procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.

These procedures must ensure that:

All complaints are processed in a uniform and timely manner.
Oral complaints are documented upon receipt.
Complaints are evaluated to determine if they represent an event requiring mandatory reporting to FDA under part 803 (Medical Device Reporting - MDR).
For devices classified under Class I, even if they are exempt from most Quality System Regulation requirements, they are still explicitly subject to § 820.198, with respect to complaint files.

Investigation and Documentation

Every complaint must be reviewed and evaluated to determine whether an investigation is necessary.

Mandatory Investigation

Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless an investigation has already been performed for a similar complaint and is not necessary.

Decision Not to Investigate

When no investigation is conducted, the manufacturer must maintain a record detailing the reason for the decision not to investigate and the name of the individual responsible for that decision.

Investigation Requirements

When an investigation is performed, the record of the investigation must include:

The name of the device.
The date the complaint was received.
Any Unique Device Identifier (UDI) or Universal Product Code (UPC), and control number(s) used.
The name, address, and phone number of the complainant.
The nature and details of the complaint.
The dates and results of the investigation.
Any corrective action taken.
Any reply to the complainant.

Manufacturers must retain the records relating to an adverse event (MDR event files) for 2 years from the date of the event or a period equivalent to the expected life of the device, whichever is greater.

Link to Medical Device Reporting (MDR)

The most critical function of the complaint system is to identify reportable adverse events under FDA Part 803: Medical Device Reporting (MDR).
A complaint becomes an MDR reportable event for a manufacturer or importer if the information reasonably suggests that a marketed device:

May have caused or contributed to a death or serious injury.

Has malfunctioned and the device, or a similar device marketed by the manufacturer or importer, would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Reporting Requirements and Timelines:

Reporting Requirements Table

Reporting Requirements for Incidents

Reporting Entity	Incident Type	Timing Requirement	Recipient
User Facility (e.g., Hospital)	Death	No later than 10 work days after awareness	FDA and the manufacturer (if known)
User Facility	Serious Injury	No later than 10 work days after awareness	Manufacturer (or FDA if manufacturer is unknown)
Manufacturer or Importer	Death, Serious Injury, or Reportable Malfunction	No later than 30 calendar days after awareness	FDA (for manufacturers) or FDA and manufacturer (for importers)

Note: If a manufacturer receives a service report that must be reported to the FDA under Part 803, they must automatically consider that report a complaint and process it according to the complaint requirements (§ 820.198)

Link to Corrective and Preventive Action (CAPA)

Complaints often serve as the trigger for the larger CAPA process. The analysis of complaints is a source of quality data used to identify existing and potential quality problems or causes of nonconforming products.

If a systematic problem is identified from complaints (e.g., users report insulin pump malfunctions affecting dosage accuracy), a CAPA investigation must be initiated to assess the reports, conduct root cause analysis, and implement corrective actions (e.g., software debugging and strengthening pre-market validation) to resolve the issue and prevent recurrence.

For certain in vitro diagnostic devices, manufacturers must submit a log of all complaints (including type of event, lot, date, population, and whether reported under Part 803) annually for five years following clearance of a traditional premarket notification.

‍