The U.S. Food and Drug Administration (FDA) has issued a draft guidance document for its proposed policies for predetermined change control plans (PCCPs) for medical devices.
The guidance provides the FDA's current thinking and recommendations on the information to include in a PCCP in a marketing submission for a device. PCCPs allow manufacturers to make some specific changes and updates to FDA-cleared or approved devices without having to resubmit them through the regulatory process.
In the guidance, the FDA includes recommendations that it believes to be appropriate to include in a PCCP, specifying that "for purposes of this guidance, a PCCP includes those device modifications that generally would otherwise require a new marketing submission." Such modifications would include "any that could significantly affect, or that otherwise affect," the safety or effectiveness of the device unless the modifications in question are covered by an authorized PCCP.
The guidance, while still a draft, gives examples of modifications that generally may be appropriate for inclusion in a PCCP (e.g., "certain" changes in device design or materials/components, "certain" changes in software used to modify device compatibility and/or interoperability, or used to improve performance), as well as a list of those that the agency would consider not appropriate for a PCCP (e.g., "significant" changes to device design or materials/components, changes that may require new clinical data to validate, and changes made to address a recall or safety issue.)
As a rule, the FDA guidelines state that modifications appropriate for inclusion in a PCCP include those that are intended to "maintain or improve the safety or effectiveness of the device." These modifications should be specific, the guidance said, and should be able to be verified and validated. Modifications included in a PCCP must maintain the device's intended use and the guidance suggests, must "allow the device to remain substantially equivalent to the predicate device." Generally, the PCCP modifications should not change the device's indications for use, the guidance states.
One important recommendation in the guidance is that manufacturers note in the labeling that the device has an authorized PCCP, with the FDA commenting that the information on the PCCP may be necessary for a user to understand the changes that have been made to a device to use it safely and effectively. Furthermore, the PCCP should be "described in publicly available device summaries" for the same reason.
The draft guidance is open for public comment until November 20, 2024.
