# Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" :  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/use-of-international-standard-iso-10993-1-biological-evaluation-of-medical-devices-part-1-evaluation-and-testing-within-a-risk-management-process-guidance-for-industry-and-food-and-drug-administration-staff/0a520dd9-604d-4769-aa08-2214730129e1

> FDA guidance document: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" :  Guidance for Industry and Food and Drug Administration Staff. Issue date: September 08, 2023. Get complete insights and analysis.

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## Details

- Title: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" :  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: 2023-09-08
- Last Changed: 2024-09-05
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2013-D-0350">FDA-2013-D-0350</a>

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