FDA's Predetermined Change Control Plan: What's in the New Draft Guidance

The US Food and Drug Administration (FDA) has recently released a draft guidance on the use of predetermined change control plans (PCCP) in marketing submissions for medical devices. 

The FDA’s change control guidance provides the agency’s recommendations on the types of modifications that are appropriate for a PCCP and the information that should be included in a PCCP marketing submission. I’ll go through some of the major points from the draft guidance, though the document itself is well worth your time if you’re looking for a way to potentially reduce the regulatory burden on your device post-approval.

BONUS RESOURCE: Click here to download our FDA pre-submission meeting checklist for free!

What is a predetermined change control plan according to FDA?

A predetermined change control plan includes specific changes or modifications to a device that generally would otherwise require a new marketing submission. However, when the modifications are described in a PCCP and included in the initial marketing submission, these changes may be implemented without a new submission (such as a special 510(k)). 

If you’re already somewhat familiar with PCCPs, that’s likely because this is not the first time FDA has written about them. The agency first described the concept of a predetermined change control plan in its 2017 guidance regarding when to submit a new 510(k) for an existing device. 

However, the phrase “predetermined change control plan” was first used a couple of years later, in their 2019 discussion paper on modifying AI/ML-based software as a medical device (SaMD). That led to a 2023 draft guidance on PCCP for AI/ML-enabled device software functions. 

Now, FDA is putting forward a more general draft guidance for PCCPs, intending to establish best practices for what to include in a PCCP in a marketing submission for your device. While earlier documents focused on AI/ML applications in SaMD, as we’ll see, FDA sees opportunities for traditional medical devices to use PCCP submissions, as well. 

When should you use the FDA's change control plan?

In general, the type of modifications included in a PCCP are those that “could significantly affect, or that otherwise affect, the safety or effectiveness of a device, unless those modifications are covered by an authorized PCCP.” In other words, without a PCCP, this type of modification would require a new marketing submission. 

The three regulatory pathways where a PCCP may be appropriate are:

1. 510(k) 

2. Premarket Approval (PMA) 

3. De Novo 

Any modification included in a PCCP should be specific and must be able to be verified and validated. The modification must also maintain the device within its intended use and indications for use, and, if applicable, it must allow it to maintain substantial equivalence with its predicate device. 

Risk is another important factor when you are considering potential modifications to include in a predetermined change control plan. FDA’s change control guidance states:

Modifications that could introduce new risks are generally not appropriate for inclusion in a PCCP because the risks of implementing the modification are likely not adequately mitigated by the existing risk management framework of the device and the manufacturer’s quality system.

However, the agency goes on to write that modifications which modify existing risks may be appropriate for inclusion in the PCCP if the risks of implementing the change are appropriately mitigated in the device’s risk management framework.

What are some examples of changes that may be appropriate for a PCCP?

Given that the 510(k) and De Novo pathways are reserved for low-to-moderate risk devices, while PMA is for high-risk devices, the types of modifications appropriate for each regulatory submission differ. 

Here are some of the general examples FDA gives of changes that would be appropriate for a PCCP for a 510(k) submission or De Novo classification request: 

• Certain changes in device design, including dimensions, performance specifications, wireless communication, components or accessories, or the patient/user interface 

• Change in sterilization, packaging, transport, or expiration dating using well-established methods

• Certain changes in software related to device compatibility and/or interoperability (e.g., changes to support device use on additional operating system(s), new data vendors and/or sources, or compatibility with additional devices) 

• Certain changes in software consistent with the intended use to improve device performance 

Here are some examples of changes that are likely not appropriate for a PCCP in a 510(k) submission or De Novo request:

• Change to device control mechanism, operating principle, or energy type 

• Change in device design that could affect the intended use of the device 

• Change to or removal of contraindications 

• Change in the labeling and/or the indications for use to include a new patient population

• Changes that may need new clinical data

• Change to a device constituent part that impacts the biologic or drug constituent part

Due to the risk already involved in Class III devices and the rigor of the Premarket approval process, the modifications appropriate for a PCCP in a PMA submission are typically minor. They could include:

• Minor change in device design, including dimensions, performance specifications, wireless communication, components or accessories, or the patient/user interface 

• Minor change in software related to device compatibility and/or interoperability (e.g., changes to support device use on upgraded operating system(s) or new data vendors and/or sources) 

• Minor change in software consistent with the intended use to improve device performance

Significant changes, such as those to components, materials, labeling, design, specification, or software are generally not appropriate for a PCCP in a PMA submission.

What will you need to include in your PCCP submission?

Your PCCP submission must include a detailed Description of Modifications, a Modification Protocol, and an Impact Assessment to help FDA review and evaluate your proposed modifications.

Description of modifications

In this section, you’ll describe the specific, planned modifications to the device that you intend to implement. It should include the specifications for the characteristics and performance of the device that can be implemented following verification and validation. 

Here, FDA recommends that you list every individual proposed modification, along with the specific rationale for each of them. And keep in mind, the agency also wants these modifications explained “at a level of detail that permits understanding of the specific modifications that will be made to the device.” 

Modification protocol

The modification protocol should describe the methods you’ll use when developing, validating, and implementing the changes outlined in your Description of Modifications section. The Modification Protocol also needs to include the verification and validation activities you’ll perform, including pre-defined acceptance criteria and a step-by-step description of how you’ll implement the modifications while ensuring the device remains safe and effective. 

It’s important to note here that FDA specifically mentions that all of these activities must be documented in your QMS in compliance with 21 CFR Part 820. 

Impact assessment

The Impact Assessment portion of your PCCP is essentially a risk-benefit analysis of your modifications, along with how you plan to mitigate those risks. Again, FDA points out that you should conduct your Impact Assessment within your QMS, as you would any other risk activities.

The Impact Assessment should:

• Compare the version of the device with each modification implemented individually to the version of the device without any modifications implemented 

• Discuss the benefits and risks, including risks of harm, of each individual modification

• Discuss how the verification and validation activities proposed within the Modification Protocol continue to reasonably ensure the safety and effectiveness of the device

• Discuss how the implementation of one modification impacts the implementation of another

• Describe the cumulative impact of implementing all modifications

When we take a step back, the PCCP submission really boils down to three questions:

1. What modifications are we planning on making? (Description of Modifications)

2. How will we make them while maintaining safety and effectiveness? (Modification Protocol)

3. What will be the effect of these modifications, and is the risk acceptable? (Impact Assessment)

This is still a draft guidance, and there are plenty of things that FDA may change as it evaluates the feedback it gets on this draft. But now is the time to start familiarizing yourself with what FDA expects in a PCCP submission. The potential to get ahead of modifications that you know will occur, and avoid more regulatory submissions down the line, could be very beneficial to a lot of MedTech companies. 

(And remember, you will be able to make comments on the draft until Nov. 20, 2024.)

BONUS RESOURCE: Click here to download our FDA pre-submission meeting checklist for free!

The key to a successful regulatory submission is still your QMS

If you do choose to use a PCCP in your regulatory submission, you can be sure that your risk analysis, verification and validation activities, and all your related documentation will get a close look from FDA. But whether you’re working on SaMD with AI/ML or just a good old-fashioned catheter, the best way to stay on the right side of regulations is the same as it always has been—using a QMS software that’s built specifically and exclusively for the MedTech industry. 

With Greenlight Guru Quality, you get a scalable quality management system with end-to-end traceability, helping you stay audit ready at all times. Our QMS comes pre-validated per FDA best practices, so you can ensure compliance with regulatory requirements from the very start. 

If you want to see how a purpose-built QMS can help you deliver high quality medical devices to patients, then get your free demo of Greenlight Guru today ➔