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FDA extends the use of predetermined change control plans beyond AI/ML devices

The Food and Drug Administration recently issued new draft guidance,  that allows predetermined change control plans (PCCPs) for all medical devices, in contrast to the 2023 draft guidance that was limited to PCCPs for artificial intelligence/machine learning enabled-devices. 

By including a PCCP in a marketing submission, manufacturers can prospectively specify and seek premarket authorization for intended modifications without needing to submit additional marketing submissions or obtain further FDA authorization. Per the draft, final guidance documents will clarify that a new premarket approval (PMA) supplement, 510(k), or De Novo submission will not be required for a change to a device consistent with an authorized PCCP. A PCCP can be submitted with a PMA or PMA supplement, a traditional or abbreviated 510(k), or a De Novo application.

The new draft guidance allows for manufacturers to implement postmarket medical device changes by submitting a PCCP during the original marketing application. The PCCP documentation describes what modifications will be made to a medical device and how these modifications will be assessed. According to the guidance, PCCPs should include:

• A description of modifications, describing "specific changes to the device characteristics and performance resulting from implementation of the modifications"
• A modification protocol, including the verification and validation activities as well as "pre-defined acceptance criteria, for those modifications, and a step-by-step delineation of how those modifications will be implemented while assuring the device remains safe and effective"
• Traceability "between the Description of Modifications and Modification Protocol"
• An impact assessment, documenting "the assessment of the benefits and risks of implementing a PCCP for a device, as well as the mitigations of those risks"

Example planned modifications

The draft guidance provides samples of planned modifications that can be accommodated by PCCPs, e.g., the addition of a new wireless card to a medical device that may initially operate over a wired network. Such a predetermined change enables medical device manufacturers to consider newer environments where their device may be installed or used after deploying the first generation to market.

Another example included in the draft guidance discusses upgrading the operating system on a device. Cybersecurity risks and other bugs are often identified in devices after they are deployed to the field. Risk assessments may show that a newer OS significantly impacts the performance of software. The draft guidance discusses how a PCCP would allow medical device manufacturers to update operating systems after completing appropriate verification and validation activities based on the modification protocol, without requiring a new marketing submission to FDA.

A third example included in the draft guidance discusses changes in sterilization of a device using well-established methods. The draft guidance discusses that a change from an Established Category A to Established Category B sterilization method may generally be appropriate for inclusion in a PCCP when the risks of implementing the modification are adequately mitigated by the existing risk management framework of the device and the manufacturer's quality system. 

Limited scope of PCCP-eligible changes

Not all types of modifications are considered appropriate for inclusion in a PCCP:

• Changes that would not otherwise require a new submission should not be included in the PCCP
• 510(k) devices that have "modifications that could significantly modify an existing risk" by changing "the risk score, risk acceptability category, or duration of risk" can be considered for a PCCP, but "not for modifications that introduce a new risk," even if the modified device remains substantially equivalent to the predicate device
• PMA devices that have major changes or changes that modify the intended use of the device may not be considered for PCCPs

Future outlook

The new draft guidance proposes to significantly reduce the burden on device manufacturers looking to improve their medical devices by reducing the requirement to submit new documentation for changes that are consistent with an authorized PCCP. Manufacturers should prospectively consider what changes or improvements they may want to bring to a device they are submitting for FDA's authorization and should also consider whether such changes may be appropriate for inclusion in a PCCP.

Comments on the draft guidance may be submitted until Nov. 20 by clicking .