# Electronic Submission Template for Medical Device De Novo Requests:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/electronic-submission-template-for-medical-device-de-novo-requests-guidance-for-industry-and-food-and-drug-administration-staff/8bd49234-647d-4582-b2b5-adc2a5d75f1c

> FDA guidance document: Electronic Submission Template for Medical Device De Novo Requests:  Guidance for Industry and Food and Drug Administration Staff. Issue date: August 23, 2024. Get complete insights and analysis.

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## Details

- Title: Electronic Submission Template for Medical Device De Novo Requests:  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: 2024-08-23
- Last Changed: 2024-08-22
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-3788">FDA-2023-D-3788</a>

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