# Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/predetermined-change-control-plans-for-medical-devices-draft-guidance-for-industry-and-fda-staff/693b4b6d-283e-481a-bbdf-352498ee619e

> FDA guidance document: Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff. Issue date: August 22, 2024. Get complete insights and analysis.

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## Details

- Title: Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff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: 2024-08-22
- Comment Close Date: 2024-11-20
- Last Changed: 2024-08-22
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2024-D-2338">FDA-2024-D-2338</a>

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