# Qualification of Medical Device Development Tools:  Guidance for Industry, Tool Developers, and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/qualification-of-medical-device-development-tools-guidance-for-industry-tool-developers-and-food-and-drug-administration-staff/392746b7-77c7-453d-abc3-dea7880c9864

> FDA guidance document: Qualification of Medical Device Development Tools:  Guidance for Industry, Tool Developers, and Food and Drug Administration Staff. Issue date: July 17, 2023. Get complete insights and analysis.

---

## Details

- Title: Qualification of Medical Device Development Tools:  Guidance for Industry, Tool Developers, and Food and Drug Administration Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2023-07-17
- Last Changed: 2023-07-17
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2013-D-1279">FDA-2013-D-1279</a>

## Related Documents

- [Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/assessing-the-credibility-of-computational-modeling-and-simulation-in-medical-device-submissions-guidance-for-industry-and-food-and-drug-administration-staff/deda9f0c-89aa-46ae-8793-ff31b91a4909)
- [Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency :  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/enforcement-policy-for-face-masks-and-barrier-face-coverings-during-the-coronavirus-disease-covid-19-public-health-emergency-guidance-for-industry-and-food-and-drug-administration-staff/d5e9f013-a025-42cb-85f6-421dba8c2dc5)
- [Off-The-Shelf Software Use in Medical Devices:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/off-the-shelf-software-use-in-medical-devices-guidance-for-industry-and-food-and-drug-administration-staff/e6562455-523c-4460-ae34-ee4678a33a70)