The New US FDA Predetermined Change Control Plans (PCCPs)

The US FDA is proposing a new addition to 510(k)s and PMA submissions:  Predetermined Change Control Plans (PCCPs) for devices requiring premarket approval (PMA) or premarket notification (510(k)).  A PCCP is the documentation describing what modifications will be made to a device and how the modifications will be assessed.

A recently published draft guidance, “Predetermined Change Control Plans for Medical Devices”, Draft Guidance for Industry and FDA Staff, for comment only, issued on August 22, 2024, provides FDA’s current thinking on the information to include in a PCCP.  It is also soliciting comments from stakeholders as to the proposals it discusses.  This draft guidance recommends that a PCCP describe the planned device modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of their impact.

FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device, without necessitating additional marketing submissions for implementing each modification described in the PCCP.  By including a PCCP in a marketing submission for a device, manufacturers can prospectively specify and seek premarket clearance / approval for intended future modifications to a device without needing to submit additional marketing submissions or obtain further FDA authorization before implementing such modifications – provided the changes are consistent with the PCCP that has been submitted and FDA-reviewed / cleared / approved.

Obviously this is a provision where future changes / models / improvements are basically known at the time of the original 510(k) or PMA submission.  For changes made to address unforeseen issues at the time of initial submission, the two guidance documents of changes to devices needing a new submission would apply instead.  

-- jel@jelincoln.com