# Evidentiary Expectations for 510(k) Implant Devices: Draft Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/evidentiary-expectations-for-510k-implant-devices-draft-guidance-for-industry-and-food-and-drug-administration-staff/023e407a-7df9-45f5-ba8c-31b660b7ab79

> FDA guidance document: Evidentiary Expectations for 510(k) Implant Devices: Draft Guidance for Industry and Food and Drug Administration Staff. Issue date: September 07, 2023. Get complete insights and analysis.

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## Details

- Title: Evidentiary Expectations for 510(k) Implant Devices: Draft Guidance for Industry and Food and Drug Administration Staff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: 2023-09-07
- Comment Close Date: 2023-12-06
- Last Changed: 2023-09-06
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-3132">FDA-2023-D-3132</a>

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