# Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/quality-management-system-information-for-certain-premarket-submission-reviews-draft-guidance-for-industry-and-food-and-drug-administration-staff/6017369f-a44a-4101-8846-ead2d67839b2

> FDA guidance document: Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff. Issue date: October 27, 2025. Get complete insights and analysis.

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## Details

- Title: Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff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: 2025-10-27
- Last Changed: 2025-10-27
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2025-D-4051">FDA-2025-D-4051</a>

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