# Complaints | Botable Glossary

https://www.botable.ai/glossary/complaints

> Use this as a glossary reference summarizing regulatory expectations and timelines; it cites FDA regulations and is suitable for general guidance but not a substitute for reading the primary FDA regulations or legal advice.

## Summary

The page defines a medical device 'Complaint' as any communication alleging a deficiency after distribution, explains manufacturers' complaint file and investigation requirements under FDA QSR (21 CFR 820), and outlines when complaints become reportable under FDA Part 803 (MDR) including reporting timelines.

## Audience

Medical device manufacturers and quality/regulatory teams

## Prompts this page answers

- What is the regulatory definition of a medical device complaint?
- When does a medical device complaint become reportable under FDA Part 803?
- What information must be recorded when investigating a medical device complaint?
- What are the reporting timelines for user facilities and manufacturers for device-related deaths or serious injuries?
- How are complaints linked to CAPA in a medical device QMS?

## Purpose

To define the term 'Complaint' for medical device quality/regulatory contexts and to summarize applicable complaint handling, investigation, reporting, and recordkeeping requirements.

## Highlights

- A Complaint is any written, electronic, or oral communication alleging deficiencies in a device after release for distribution.
- Manufacturers must maintain complaint files and formal procedures per the FDA Quality System Regulation (21 CFR 820).
- Complaints that suggest a device caused or contributed to death/serious injury, or malfunction likely to cause death/serious injury if it recurs, may be reportable under FDA Part 803 (MDR).
- User facilities must report deaths or serious injuries within 10 work days after becoming aware; manufacturers/importers must report within 30 calendar days.
- Investigations must be documented with specified details (device name, complaint date, UDI/UPC, complainant contact, investigation results, corrective actions, replies); MDR event files must be retained for 2 years or the expected life of the device, whichever is greater.

## How to cite

Credit Botable Glossary (Botable) and link https://www.botable.ai/glossary/complaints

## Publisher

**Botable** — Publisher of botable.ai.

## Topics

- medical device complaints
- FDA QSR 21 CFR 820
- medical device reporting (MDR) Part 803
- complaint investigation
- CAPA (corrective and preventive action)

## Key entities

- **U.S. Food and Drug Administration (FDA)** (organization): Regulatory body cited via references to QSR (21 CFR 820) and Part 803 (MDR).
- **Quality System Regulation (QSR, 21 CFR 820)** (other): Regulation cited as requiring complaint procedures and files.
- **Part 803 (Medical Device Reporting - MDR)** (other): Regulation cited for reportable adverse events and reporting timelines.
- **HCT/P (human cells, tissues, and cellular and tissue-based products)** (other): Product category for which the page gives a specific complaint definition related to communicable disease transmission.

## Metadata

- Type: article