# Deciding When to Submit a 510(k) for a Software Change to an Existing Device:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/deciding-when-to-submit-a-510k-for-a-software-change-to-an-existing-device-guidance-for-industry-and-food-and-drug-administration-staff/303c36a0-3191-4197-bc16-584e24525d07

> FDA guidance document: Deciding When to Submit a 510(k) for a Software Change to an Existing Device:  Guidance for Industry and Food and Drug Administration Staff. Issue date: October 25, 2017. Get complete insights and analysis.

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## Details

- Title: Deciding When to Submit a 510(k) for a Software Change to an Existing Device:  Guidance for Industry 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: 2017-10-25
- Comment Close Date: 2016-11-06
- Last Changed: 2020-03-02
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2016-D-2021">FDA-2016-D-2021</a>

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