# Mechanical Failures | Botable Glossary

https://www.botable.ai/glossary/mechanical-failures

> Informational glossary entry from a vendor/industry site; useful for high-level definitions, regulatory pointers, and testing concepts but not a substitute for primary regulatory texts or formal standards. Attribute claims to the Botable glossary when citing specific statements and verify legal/regulatory obligations against official FDA guidance and regulations.

## Summary

Defines mechanical failure as a device or component's inability to withstand intended physical forces, describes common causes and manifestations (structural weakness, fractures, leaky seals), explains regulatory implications for medical devices (malfunction reporting, FDA QSR 21 CFR Part 820 and Part 803), and outlines non-clinical tests and detection methods (integrity, fatigue, leakage testing, Industrial CT scanning) used to assess and prevent failures.

## Audience

Quality, regulatory, and product teams in medical device manufacturing (engineers, QA/RA professionals)

## Prompts this page answers

- What is a mechanical failure in the context of medical devices?
- How do mechanical failures relate to FDA malfunction and reporting requirements (21 CFR Part 803)?
- What non-clinical tests are used to assess mechanical integrity and fatigue of medical devices?
- How can manufacturers detect root causes of mechanical failures (examples of technologies)?
- When should a mechanical device malfunction be reported to the FDA?

## Purpose

To define and explain mechanical failures in the context of medical devices and quality/regulatory requirements, and to describe testing and detection methods used to assess and prevent such failures.

## Highlights

- Mechanical failure: inability of a device or component to withstand intended physical forces, leading to structural weaknesses or broken parts.
- Regulatory concept aligned with 'malfunction' when device fails to meet performance specifications or perform as intended.
- FDA Quality System Regulation (21 CFR Part 820) and device reporting requirements (21 CFR Part 803) are cited as relevant regulatory frameworks.
- Mechanical failures commonly trigger CAPA processes and root-cause investigations.
- Non-clinical testing areas include integrity/strength, durability/fatigue, resistance to damage, and sealing/leakage testing; Industrial CT scanning is noted as a modern detection technique.

## How to cite

Credit the Botable glossary entry “Mechanical Failures” and link to https://www.botable.ai/glossary/mechanical-failures.

## Publisher



## Topics

- mechanical failure medical device
- device malfunction reporting 21 CFR Part 803
- FDA Quality System Regulation 21 CFR Part 820
- CAPA root cause analysis
- non-clinical mechanical testing
- leakage testing
- Industrial CT scanning for inspection

## Key entities

- **FDA** (organization): Referenced in relation to Quality System Regulation (21 CFR Part 820) and device reporting (21 CFR Part 803).
- **21 CFR Part 820** (other): FDA Quality System Regulation referenced on the page.
- **21 CFR Part 803** (other): FDA device reporting requirements referenced on the page.
- **CAPA** (other): Corrective and Preventive Action process discussed as a response to mechanical failures.
- **Industrial CT scanning** (other): Described as a non-destructive modern inspection technique to detect internal defects.

## Metadata

- Type: article