# De Novo Classification Process (Evaluation of Automatic Class III Designation):  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/de-novo-classification-process-evaluation-of-automatic-class-iii-designation-guidance-for-industry-and-food-and-drug-administration-staff/c07fa6ad-91f7-456d-b51e-780b71d784f5

> FDA guidance document: De Novo Classification Process (Evaluation of Automatic Class III Designation):  Guidance for Industry and Food and Drug Administration Staff. Issue date: October 05, 2021. Get complete insights and analysis.

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## Details

- Title: De Novo Classification Process (Evaluation of Automatic Class III Designation):  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: 2021-10-05
- Last Changed: 2022-02-18
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2011-D-0689">FDA-2011-D-0689</a>

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