 
Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Predetermined Change Control Plans for Medical Devices.
This draft guidance proposes a policy for predetermined change control plans (PCCPs) and recommendations on the information to include in a PCCP in a marketing submission for a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.
Note: This guidance is not for implementation at this time.
Submit comments on this draft guidance
Submit comments under docket number FDA-2024-D-2338 at www.regulations.gov by November 20, 2024 to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.
Upcoming webinar on this guidance
On September 3, 2024, the FDA will host a webinar for industry and others interested in learning more about the draft guidance.
Questions?
If you have questions about this draft guidance, contact RPG@fda.hhs.gov. If you have questions about the webinar, contact the Division of Industry and Consumer Education.
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