# Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers: Draft Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/transfer-of-a-premarket-notification-510k-clearance-questions-and-answers-draft-guidance-for-industry-and-food-and-drug-administration-staff/76eacc48-6d53-40f0-80fb-98adbfc5c390

> FDA guidance document: Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers: Draft Guidance for Industry and Food and Drug Administration Staff. Issue date: June 05, 2025. Get complete insights and analysis.

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## Details

- Title: Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers: Draft Guidance for Industry and Food and Drug Administration Staff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: 2025-06-05
- Comment Close Date: 2025-08-04
- Last Changed: 2025-06-04
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2024-D-1528">FDA-2024-D-1528</a>

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