List of FDA authorized devices with Predetermined Change Control Plans
This page lists medical devices that have FDA authorized Predetermined Change Control Plans (PCCPs) based on searches of device authorization letters and approval order statements.
The information on this page is based on sources in the public domain. It is provided here “as-is” without warranty of any kind. For reliable and up-to-date information, refer to the FDA’s website.
For devices with 510(k)s, this list should include search results as of about 2025-03-05. For devices with De Novos, this list should include search results as of about 2025-01-17. For devices with PMAs, this list should include search results as of about 2025-03-09.
As explained in this post, the search results shown here may not include every device with a PCCP, and the search results shown here may include some devices that do not actually have a PCCP. It’s important to treat these search results, and any analyses based on these search results, as preliminary estimates. For example, the FDA sometimes sends authorization letters saying PCCPs are present when they aren’t. When the FDA finds these mistakes, they send new letters to correct them. This may lead to devices being removed from the list. You can download a CSV file with details on devices affected by these corrections: Corrections (CSV).
You can also download a CSV file with details about the devices on this list: Raw data (CSV).
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Citation
@online{o'leary2024,
author = {O’Leary, Brendan},
title = {List of {FDA} Authorized Devices with {Predetermined}
{Change} {Control} {Plans}},
date = {2024-08-20},
url = {https://www.boleary.com/blog/posts/202407-pccp/latest/},
langid = {en},
abstract = {This page lists medical devices that have FDA authorized
Predetermined Change Control Plans (PCCPs) based on searches of
device authorization letters and approval order statements.}
}