# Content of Premarket Submissions for Device Software Functions:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/content-of-premarket-submissions-for-device-software-functions-guidance-for-industry-and-food-and-drug-administration-staff/0cee2fd2-94a6-466f-b1b8-836fd3c8d30f

> FDA guidance document: Content of Premarket Submissions for Device Software Functions:  Guidance for Industry and Food and Drug Administration Staff. Issue date: June 14, 2023. Get complete insights and analysis.

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## Details

- Title: Content of Premarket Submissions for Device Software Functions:  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: 2023-06-14
- Last Changed: 2023-08-14
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2021-D-0775">FDA-2021-D-0775</a>

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