# Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/procedures-for-class-ii-device-exemptions-from-premarket-notification-guidance-for-industry-and-cdrh-staff/b63609b3-e69f-44e1-9551-7f9686852c3f

> FDA guidance document: Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff. Issue date: February 18, 1998. Get complete insights and analysis.

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## Details

- Title: Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH 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: 1998-02-18
- Last Changed: 2020-02-28
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-N-1129">FDA-2017-N-1129</a>

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