List of FDA authorized devices with Predetermined Change Control Plans

datasets
FDA
medical devices
Author

Brendan O’Leary

Published

2024-08-20

Modified

2026-08-21

Summary

This page lists medical devices that have FDA authorized Predetermined Change Control Plans (PCCPs), drawing on both a search of device authorization letters and approval order statements and the FDA’s own premarket databases.

Note

The information on this page is based on sources in the public domain. It is provided here “as-is” without warranty of any kind. You may also want to refer to the FDA’s website.

In May 2025, the FDA added a PCCP search feature to its 510(k), De Novo, and PMA databases. This page now combines the FDA’s list with the search method described here. The Source column records which of the two flagged each authorization, and the table can be filtered on it:

  • FDA list + text search: Both methods agree (highest confidence).
  • FDA list only: On the FDA’s list but the text search did not surface it.
  • Text search only: The text search flagged it but it is not on the FDA’s list.

For devices with 510(k)s, this list should include search results as of about 2026-07-31. For devices with De Novos, this list should include search results as of about 2026-07-28. For devices with PMAs, this list should include search results as of about 2026-08-14. The FDA list reflects a snapshot taken on 2026-08-21.

The list shown here may not include every device with a PCCP, and it may include some devices that do not actually have a PCCP. It’s important to treat this list, and any analyses based on it, 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).

Table 1: List of FDA authorized devices with PCCPs, with the source(s) that flagged each. Raw data (CSV).
Figure 1: Approximate number of submissions authorized by the FDA with a PCCP. Raw data (CSV).
Figure 2: Approximate number of submissions authorized by the FDA with a PCCP by panel. Raw data (CSV).

Reuse

Citation

BibTeX citation:
@online{o'leary2026,
  author = {O’Leary, Brendan},
  title = {List of {FDA} Authorized Devices with {Predetermined}
    {Change} {Control} {Plans}},
  date = {2026-08-21},
  url = {https://www.boleary.com/pccp/},
  langid = {en},
  abstract = {This page lists medical devices that have FDA authorized
    Predetermined Change Control Plans (PCCPs), drawing on both a search
    of device authorization letters and approval order statements and
    the FDA’s own premarket databases.}
}
For attribution, please cite this work as:
B. O’Leary, “List of FDA authorized devices with Predetermined Change Control Plans,” Aug. 21, 2026. https://www.boleary.com/pccp/