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  4. Webinar - Draft Guidance: Predetermined Change Control Plans for Medical Devices - 09/03/2024
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Webcast | Virtual

Event Title
Webinar - Draft Guidance: Predetermined Change Control Plans for Medical Devices
September 3, 2024

Date:
September 3, 2024
Time:
1:00 PM - 2:30 PM ET

Summary

On September 3, 2024, the FDA held a webinar for industry and other interested stakeholders to answer questions about the draft guidance: Predetermined Change Control Plans for Medical Devices.

Background

This draft guidance proposes a policy for predetermined change control plans (PCCPs) and recommendations on the information to include in a PCCP in a marketing submission for a device. 

The FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without needing to submit additional marketing submissions or obtain further FDA authorization before implementing each modification described in the PCCP.

Webinar Materials

The presentation, printable slides, and transcript are available at CDRH Learn under “How to Study and Market Your Device,” sub-section “Cross-Cutting Premarket Policy.” 

If you have questions about this draft guidance document, please contact the CDRH Office of Product Evaluation and Quality (OPEQ) Regulation, Policy, and Guidance (RPG) staff at RPG@fda.hhs.gov. If you have questions about this webinar, please contact CDRH’s Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100, 1-800-638-2041, or 301-796-7100.

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