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FDA Predetermined Change Control Plan (PCCP) Template

Thanks for your interest in our FDA Predetermined Change Control Plan (PCCP) Template. Here are two versions of the template to choose from:

  1. Google docs template
  2. Word doc template

[hide-start title="Guide to using this template effectively"]

  1. Blue Text: Indicates common considerations and questions pertaining to the section. This text should be deleted prior to finalizing the document.
  2. Red Text: Indicates content that should be replaced with product- and manufacturer-specific information for the ease of use of this template. Red text also indicates the presence of hypothetical medical device information. This information should not be present in your PCCP.

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[hide-start title="Steps to complete the PCCP template"]

  1. Read through the template: Understand the contents of each section and how it could apply to your product. The example medical device content provided could give you an idea for what information you may want to include in your PCCP. 
  2. Customize the Template: Replace all red text with specific information about your medical device and organization.
  3. Describe the ML-DSF: Provide details about the ML-DSF units in your device, including an architecture diagram and a description of how they fulfill the intended use of the product.
  4. Outline Modifications: Clearly describe each planned modification, ensuring that they are specific, verifiable, and appropriate for a PCCP. Address the questions provided in the template to ensure a comprehensive description.
  5. Develop the Modification Protocol: Use the template sections on Data Management Practices, Re-Training Practices, Performance Evaluation, and Update Procedures to develop a detailed protocol for implementing and assessing modifications.
  6. Assess the Impact: Evaluate the impact of each modification and the collective impact of all modifications on the safety and effectiveness of the device.

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[hide-start title="Example Medical Device Description"]

The example provided in this template is a wearable medical device that incorporates a Machine Learning Device Software Function (ML-DSF). The ML-DSF is capable of predicting and diagnosing healthcare conditions using sensor data. It features a core algorithm that can be updated remotely and a personal ML-DSF algorithm that continuously learns from the user's real-world data. The modifications outlined in this template include weekly core algorithm re-training

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[hide-start title="Disclaimer"]

The example provided in this template, involving a wearable medical device with a Machine Learning Device Software Function (ML-DSF), is for illustrative purposes only. It is intended to demonstrate how to apply the template to a hypothetical medical device and is not representative of any specific product or manufacturer. Users of this template should replace the example with details specific to their own medical device and organization

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