# Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/submission-and-review-of-sterility-information-in-premarket-notification-510k-submissions-for-devices-labeled-as-sterile-guidance-for-industry-and-food-and-drug-administration-staff/f615a298-5533-4084-b9bc-068bd55bb558

> FDA guidance document: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile:  Guidance for Industry and Food and Drug Administration Staff. Issue date: January 08, 2024. Get complete insights and analysis.

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## Details

- Title: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile:  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: 2024-01-08
- Last Changed: 2024-01-08
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2008-D-0611">FDA-2008-D-0611</a>

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