# Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/intent-to-exempt-certain-unclassified-medical-devices-from-premarket-notification-requirements-guidance-for-industry-and-food-and-drug-administration-staff/ae5f7c98-ea68-4e18-8938-1480cb9790ee

> FDA guidance document: Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements:  Guidance for Industry and Food and Drug Administration Staff. Issue date: June 05, 2026. Get complete insights and analysis.

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## Details

- Title: Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements:  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: 2026-06-05
- Last Changed: 2026-06-04
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2014-D-0967">FDA-2014-D-0967</a>

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