# Software as a Medical Device (SAMD): Clinical Evaluation:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/software-as-a-medical-device-samd-clinical-evaluation-guidance-for-industry-and-food-and-drug-administration-staff/745234d9-1b52-4aa1-aff4-297a93f801f8

> FDA guidance document: Software as a Medical Device (SAMD): Clinical Evaluation:  Guidance for Industry and Food and Drug Administration Staff. Issue date: December 08, 2017. Get complete insights and analysis.

---

## Details

- Title: Software as a Medical Device (SAMD): Clinical Evaluation:  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: 2017-12-08
- Last Changed: 2021-03-19
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2016-D-2483">FDA-2016-D-2483</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)
- [Deciding When to Submit a 510(k) for a 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-change-to-an-existing-device-guidance-for-industry-and-food-and-drug-administration-staff/d023d66b-8356-4ef3-8e0a-ad5948dc5732)
- [Medical Device Reporting for Manufacturers :  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/medical-device-reporting-for-manufacturers-guidance-for-industry-and-food-and-drug-administration-staff/bdf0f904-24f2-44f0-8046-74c1e429237a)