# Premarket Approval Application and Humanitarian Device Exemption Modular Review:  Guidance for Industry and FDA Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/premarket-approval-application-and-humanitarian-device-exemption-modular-review-guidance-for-industry-and-fda-staff/101d4214-dbce-4b60-b778-d03444e69316

> FDA guidance document: Premarket Approval Application and Humanitarian Device Exemption Modular Review:  Guidance for Industry and FDA Staff. Issue date: January 13, 2025. Get complete insights and analysis.

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## Details

- Title: Premarket Approval Application and Humanitarian Device Exemption Modular Review:  Guidance for Industry and FDA 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: 2025-01-13
- Last Changed: 2025-01-13
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2024-D-5332">FDA-2024-D-5332</a>

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