# The Special 510(k) Program:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/the-special-510k-program-guidance-for-industry-and-food-and-drug-administration-staff/4f4aa315-7b28-464a-abc4-9844f976f26a

> FDA guidance document: The Special 510(k) Program:  Guidance for Industry and Food and Drug Administration Staff. Issue date: September 13, 2019. Get complete insights and analysis.

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## Details

- Title: The Special 510(k) Program:  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: 2019-09-13
- Last Changed: 2019-09-12
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-3304">FDA-2018-D-3304</a>

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