# Deciding When to Submit a 510(k) for a 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-change-to-an-existing-device-guidance-for-industry-and-food-and-drug-administration-staff/d023d66b-8356-4ef3-8e0a-ad5948dc5732

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

---

## Details

- Title: Deciding When to Submit a 510(k) for a 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-2011-D-0453">FDA-2011-D-0453</a>

## Related Documents

- [Deciding When to Submit a 510(k) for a Software Change to an Existing Device:  Guidance for Industry and Food and Drug Administration Staff](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)
- [Technical Considerations for Additive Manufactured Medical Devices:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/technical-considerations-for-additive-manufactured-medical-devices-guidance-for-industry-and-food-and-drug-administration-staff/98baa3f0-2518-4f02-a853-0147f61ef069)
- [Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices :   Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/use-of-real-world-evidence-to-support-regulatory-decision-making-for-medical-devices-guidance-for-industry-and-food-and-drug-administration-staff/1de17575-088a-4770-a70b-99c29f9cf44d)