Planning device changes in advance: FDA's 2024 draft guidance on PCCPs

Almost every team that has taken a device through FDA knows this tension: the prototype sent for testing and described in the submission is rarely identical to the device that goes into production or gets its first small update. And everyone worries that the submitted version is “locked,” so that any difference from it means going through a new submission. Under the traditional rules that worry is largely justified, but it is only half of how FDA manages device changes.

The guidance

On 22 August 2024, FDA’s CDRH and CBER jointly issued draft guidance, Predetermined Change Control Plans for Medical Devices. It extends the predetermined change control plan (PCCP), which previously applied only to AI/ML-enabled device software, to all types of medical devices.

Key point: A PCCP lets you describe the changes you plan to make in the future in your marketing submission, and have them authorized together with the device. Changes made according to the plan then do not need a separate submission each time. This is a significant shift in how FDA approaches change management.

What a PCCP is

A PCCP turns “submit each change for review” into “authorize once, then follow the protocol.”

A PCCP is part of the marketing authorization. It is not a statement of intent; it is a legal document authorized together with the device. Once authorized, it is written into the device’s letter of authorization, and a manufacturer that chooses to use it must follow the authorized PCCP exactly.

It rests on three rules:

Agree in advance. The submission describes the specific planned changes (Description of Modifications), how each change will be verified and validated (Modification Protocol, with predefined acceptance criteria), and the benefit-risk assessment (Impact Assessment). These three parts are the required structure of a PCCP, and they must be linked and traceable to each other.
No new submission afterwards. A change consistent with the authorized PCCP can be implemented under the PCCP without a new marketing submission.
Deviations have consequences. Not following, or being unable to follow, the PCCP is a deviation. The device would then generally be considered adulterated under Section 501(f)(1) and misbranded under Section 502(o) of the FD&C Act, and FDA may take legal action such as seizure.

Note: A PCCP is optional, and it should not be greedy. It should cover a small number of specific changes that can be verified and validated, not a list of every change you might ever make. FDA says that if a PCCP includes too many changes, or changes across many different aspects of a device, FDA may not be able to determine safety and effectiveness or substantial equivalence.

What does “design freeze” actually freeze?

Back to the common belief at the start. Strictly speaking, “frozen” has three separate layers:

What FDA reviews is frozen. FDA reviews the specific version you submit, including any PCCP in it. That has not changed.
The device itself is not absolutely frozen. Changes within the scope of an authorized PCCP can be implemented under it, without a submission each time. That is exactly what PCCPs are for.
Significant changes outside the PCCP still need authorization first. Changes outside its scope must still be submitted and authorized before they are implemented.

In short: What is frozen at authorization is the submitted version as a baseline, especially when it is used as a predicate. The device itself is not absolutely frozen: you either submit changes one by one in the traditional way, or agree them in advance with a PCCP and implement them without new submissions.

Case study: can a PRP centrifuge use a PCCP?

Take a PRP centrifuge under product code ORG as an example.

Step 1: Establish what the device is

Key FDA facts:

Regulation: 21 CFR 864.9245, Automated blood cell separator
Class: Class II (special controls)
Review center: CBER (Center for Biologics Evaluation and Research), Hematology panel
Product code: ORG, Platelet and Plasma Separator for Bone Graft Handling
Technology: separates whole blood into components by centrifugation and/or filtration, then extracts PRP

Conclusion: A Class II device, on the 510(k) pathway, reviewed by CBER.

Step 2: PCCPs depend on the pathway, not the review center

A first instinct might be: if CBER reviews it, is it outside the scope of PCCPs?

No. Section 515C defines scope by statutory pathway, not by review center. Section 515C(a) covers devices requiring a PMA, and 515C(b) covers devices requiring a 510(k). The August 2024 draft expressly extends PCCPs to all device types, including the device constituent parts of device-led combination products. And the guidance itself was issued jointly by CDRH and CBER, with both centers listed as issuing offices.

Conclusion: 510(k) pathway → Section 515C(b) → within the scope of PCCPs. Whether CBER reviews it makes no difference.

Step 3: In scope does not mean every change fits

Whether a PCCP works depends on the change you want to make, not on the product code. Under the draft, the following changes are generally not suitable for a PCCP:

changes to the device’s control mechanism, operating principle or energy type;
design changes that could affect the intended use;
changing from single use to reusable;
changing or removing contraindications;
changing from prescription to over-the-counter (OTC);
changes that could require new clinical data;
changes made in response to a recall or safety issue.

✅ Possibly suitable: small adjustments to consumable dimensions or tubing geometry, non-functional improvements to the software interface, automation of manufacturing steps (one of the draft’s own positive examples is automating a dimensional measurement step in manufacturing).

❌ Generally not workable: changing the separation principle (for example from centrifugation to membrane filtration); extending the indication from “mixing with bone graft material to improve handling” to a new patient population or a new indication such as wounds. The latter would need new clinical data and goes beyond the intended use.

Note: Changes under a PCCP must stay within the intended use and maintain substantial equivalence to the predicate. Product code ORG itself relies on predicate comparison, which brings us back to the version freeze under Section 515C(c).

Step 4: The practical question — is it worth it?

Weighing cost and time, this device’s change management may not need a PCCP at all. Other products need case-by-case analysis.

The reasons are clear. It is a Class II device with special controls, moderate risk. A PCCP is optional. For most changes to this kind of product, the manufacturer can already decide whether a new 510(k) is needed using the logic in FDA’s guidance Deciding When to Submit a 510(k) for a Change to an Existing Device, without the heavier PCCP mechanism.

Where a PCCP really pays off: changes that are frequent and predictable, and would each trigger a new submission. The classic case is AI/ML software. For a hardware centrifuge with one or two occasional tweaks, a PCCP may not be worth the cost.

Tip: If you do go this way, FDA explicitly encourages getting feedback on the proposed PCCP through the Q-Submission (Q-Sub) program before the marketing submission, especially for combination products and higher-risk devices. Treat this step as essential.

Conclusion

PCCPs are about more than filing fewer documents. They reflect a change in how FDA thinks about the device lifecycle: devices evolve, so rather than have manufacturers come back again and again, it is better to agree the boundaries of that evolution in advance.

But “boundaries” is the key word. A PCCP covers predictable changes, not any change: a few changes within the intended use that can be verified and traced. For hardware manufacturers, our advice is to make good use of the “do I need a new 510(k)?” decision logic first, and consider a PCCP once changes become genuinely frequent and predictable.

Should your first 510(k) include a PCCP? Contact us for an assessment.

Sources

Food and Drug Omnibus Reform Act of 2022 (FDORA), in the Consolidated Appropriations Act, 2023 (Public Law 117-328, signed 29 December 2022); Section 3308 added Section 515C to the FD&C Act (21 U.S.C. 360e-4).
Predetermined Change Control Plans for Medical Devices, FDA draft guidance (Draft – Not for Implementation; non-binding), issued 22 August 2024, Docket No. FDA-2024-D-2338, prepared jointly by CDRH and CBER. Comment period: 90 days after the Federal Register notice.
21 CFR 864.9245 — Automated blood cell separator, Class II (special controls), product code ORG, reviewed by CBER, Hematology. Current eCFR.
Deciding When to Submit a 510(k) for a Change to an Existing Device — guidance on 510(k) changes.
Modifications to Devices Subject to Premarket Approval (PMA) – The PMA Supplement Decision-Making Process — guidance on PMA supplements.
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions — the 2023 draft guidance on PCCPs for AI/ML devices, predecessor and companion to the general guidance.

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This article is general information, not regulatory or legal advice for a specific device. Requirements change; check the official sources and the date above.