DHF (Design History File) is una compilación de registros que describen el historial de diseño de un dispositivo médico terminado, requerido por la FDA bajo 21 CFR Parte 820.
Complete Guide to DHF
A Design History File (DHF) is a compilation of records that describes the design history of a finished medical device. Required by FDA 21 CFR Part 820 (Quality System Regulation), the DHF documents how design controls were applied throughout the device development process.
What the DHF must contain:
- Design and development planning documents
- Design input requirements
- Design output specifications
- Design review records
- Design verification results
- Design validation results
- Design transfer records
- Design change documentation
Key elements documented:
1. Design Input - User needs, intended use, performance requirements
2. Design Output - Specifications, drawings, software code
3. Design Reviews - Meeting minutes, decisions, action items
4. Verification - Testing that outputs meet inputs
5. Validation - Testing that device meets user needs
6. Risk Management - Hazard analysis, FMEA, risk controls
7. Traceability - Requirements to testing to final device
DHF vs DMR vs DHR:
- DHF - Design History File (development records)
- DMR - Device Master Record (manufacturing specifications)
- DHR - Device History Record (production batch records)
Regulatory importance:
- Required for FDA QSR compliance
- Demonstrates design control compliance during audits
- Essential evidence for 510(k) and PMA submissions
- Similar requirements in EU MDR Technical Documentation
The DHF should be maintained throughout the product lifecycle and updated for design changes.
Related Terms
More Documentation
View allUn documento público que resume la determinación de equivalencia sustancial del 510(k) presentada a la FDA.
Una declaración escrita formal del fabricante de que un dispositivo médico cumple con todos los requisitos aplicables del MDR de la UE y está listo para el marcado CE.
Instrucciones de Uso - documentación completa proporcionada por el fabricante que brinda a los usuarios la información necesaria para el uso seguro y efectivo de un dispositivo médico.
Término específico de la FDA que describe la enfermedad o condición que el dispositivo diagnosticará, tratará, prevendrá, curará o mitigará, junto con la población de pacientes para la que está destinado el dispositivo.
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