An FDA predetermined change control plan (PCCP) is documentation that describes the modifications a manufacturer will make to a device and how they will be assessed. Once FDA authorizes it within a marketing submission, a change consistent with the plan does not need a separate supplemental application or new 510(k). FDA covers PCCPs in a 2024 draft guidance for devices generally, which is not final. It also covers PCCPs in a final guidance for AI-enabled device software functions. This guidance was first issued on December 4, 2024, and was current as of August 18, 2025.
This article focuses on eligibility requirements, the three key elements, submissions, implementation and typical compliance issues.
What Is a Predetermined Change Control Plan (PCCP)?
A PCCP is a plan, established through a device’s marketing authorization, that pre-specifies planned modifications and the methods used to assess them. Section 515C of the FD&C Act lets FDA approve or clear a PCCP for planned changes that would otherwise need a supplemental application or new 510(k). The condition is that the device remains safe and effective without those changes.
How it differs from traditional change control
Under traditional medical device change control, the manufacturer judges each change under its quality system and decides whether 21 CFR 807.81(a)(3) or 21 CFR 814.39(a) requires a new submission. A PCCP moves FDA’s review of specified changes into the original submission. Execution stays within the manufacturer’s design controls, risk management, verification, validation, and change procedures.
FDA treats a modification as consistent with an authorized PCCP only when it is both:
- specified in the Description of Modifications, and
- implemented according to the Modification Protocol.
Significant changes outside the plan likely need a new marketing submission. Deviations from an authorized PCCP would generally make the device adulterated and misbranded. Authorization therefore does not reduce the manufacturer’s duty to keep the device safe, effective, and compliant.
Latest FDA PCCP Guidance and Legal Basis
Section 515C of the FD&C Act became law on December 29, 2022. It allows FDA to:
- Approved devices (PMA): FDA may approve a PCCP if the device remains safe and effective without the change.
- Cleared devices (510(k)): FDA may clear a PCCP if the device remains safe and effective and would remain substantially equivalent to the predicate.
- Scope: FDA may require labeling, notification requirements if the device does not function as intended, and performance requirements.
- Predicates: Only the version cleared or approved before PCCP changes may serve as a predicate.
The law names PMA and 510(k) devices, while FDA guidance also covers De Novo devices.
The 2024 draft guidance: Its official title is Predetermined Change Control Plans for Medical Devices, issued August 22, 2024 (89 FR 67945).
Scope: It applies to devices, including device-led combination products, reviewed through 510(k), De Novo, and PMA .
- Status: FDA marks it “Not for implementation” and non-binding. It shows FDA’s proposed thinking, not final policy.
- Content: It covers guiding principles, types of modifications that generally may or may not suit a PCCP, recommended content, and examples.
The final AI guidance: The title is Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions. The guidance was finalized on August 18, 2025, following its initial release on December 4, 2024.
- Scope: It applies to AI-enabled device software functions (AI-DSFs), whether updates are automatic or manual.
- Recommendations: A PCCP should describe planned modifications, the methodology to develop, validate, and implement them, and an impact assessment.
- Legal weight: Its recommendations are non-binding.
Key differences in FDA PCCP guidance
| Feature | 2024 draft (general) | Final (AI-enabled) |
| Status | Draft, not for implementation | Final, non-binding |
| Scope | All device types | AI-DSFs |
| Modification Protocol | Performance evaluation methods and update procedures |
Data management, re-training, performance evaluation, update procedures
|
| Examples | Modification-type lists, device examples, sample 510(k) summary text |
Appendix A (protocol questions), Appendix B (six AI scenarios)
|
| PMA supplement types listed | Includes 135-Day supplement for manufacturing-only PCCPs |
Original, modular, 180-Day, Panel-Track, Real-Time
|
An AI-enabled device software function falls within the final guidance. A non-AI device falls outside it, so the draft is the closest FDA document. The final AI guidance’s recommendations do not automatically apply to non-AI devices, and a draft is not binding on anyone. The right document depends on the device, submission type, and proposed modifications, and FDA encourages early discussion with the review division.
Which Medical Devices and Modifications Can a PCCP Cover?
A PCCP can be authorized in 510(k), De Novo, and PMA submissions, but the basis and expectations differ by submission type. FDA decides scope device by device.
Applicability Across 510(k), De Novo, and PMA Submissions
- 510(k): The device must remain substantially equivalent, so modifications must stay within intended use. FDA lists Traditional and Abbreviated 510(k)s as appropriate submission types.
- PMA: FDA lists an original PMA, modular PMA, 180-Day, Panel-Track, and Real-Time supplements.
- De Novo: FDA lists an original De Novo request. It expects to develop special controls that may include PCCP requirements.
AI-Enabled and Non-AI Medical Devices
An AI-enabled medical device PCCP follows the final guidance. For other devices, the draft covers all device types, and its examples include IVDs, sutures, monitors, and apps. The nature of the change, device risk, and supporting evidence matter more than the AI label. FDA states that a modification suitable for one device may be unsuitable for another.
Examples of Planned Modifications
These categories come from FDA guidance. Whether a given change qualifies depends on the device, intended use, risk assessment, evidence, and authorized PCCP.
- Retraining that improves quantitative performance specifications, using new data from the same intended use population and input type.
- Compatibility changes, such as new data sources or operating systems.
- Certain software changes consistent with intended use that improve performance.
- Certain use changes for a subpopulation within the original indication.
Changes That May Fall Outside an Authorized PCCP
Changes that exceed the plan, depart from the protocol or introduce unassessed risks may need further evaluation and a new submission. The draft says modifications that could introduce a new risk are generally not appropriate for a 510(k) or De Novo PCCP.
FDA draws a firm line at intended use and a cautious line at indications for use:
- Modifications must maintain the device within its intended use.
- FDA generally expects them to stay within indications for use.
- Most indication changes are hard to assess in advance, though some narrow ones may suit a PCCP, such as use with an additional component.
- FDA highly encourages Q-Submission discussion for any such change.
What Are the Three Core Components of an FDA PCCP?
FDA recommends three components: the Description of Modifications, the Modification Protocol, and the Impact Assessment. They are interrelated. The Impact Assessment ties the first two together. The draft uses the same three terms.
| Component | Core content |
| Description of Modifications | Specific modifications, rationale, specifications |
| Modification Protocol | Methods, V&V, predefined acceptance criteria |
| Impact Assessment | Benefits, risks, interactions, cumulative effect |
Description of Modifications
This component lists each planned modification with its rationale and the specifications for device characteristics and performance. FDA recommends a limited number of modifications that are specific and can be verified and validated. It also says to state whether changes are automatic or manual, uniform or site-specific, and how often they are expected.
Vague wording makes scope hard to judge. FDA’s consistency test begins with whether the change was specified in the plan.
Modification Protocol
The protocol documents the methods for developing, validating, and implementing each modification. These include verification and validation with predefined acceptance criteria, in step-by-step form. Key elements:
- Risk management: Manufacturers follow their risk management processes for each modification.
- Traceability: Each modification links to its protocol methods, often through a traceability table.
- Failure rule: The protocol should state that an unresolvable failure is recorded and the modification is not implemented.
For AI-DSFs, the guidance adds four protocol components:
- Data management: Data should be representative of intended use populations, such as race, ethnicity, disease severity, sex, and age. Test data should be independent of training and tuning data.
- Re-training practices.
- Performance evaluation: The modified device is compared with the original and the last modified version.
- Update procedures, including real-world monitoring.
The guidance does not set universal thresholds. Criteria must be justified for the specific device, intended use, risks, and modification.
Impact Assessment
The Impact Assessment documents benefits, risks, and mitigations. It should:
- Compare each modification, implemented individually, with the unmodified device.
- Discuss benefits and risks of each modification, including unintended bias for AI-DSFs.
- Explain how verification and validation continue to ensure safety and effectiveness.
- Address how one modification affects another.
- Describe the cumulative impact of all modifications.
It also covers effects on overall device functions, including other software and hardware. The assessment supports the case that the combined modifications are unlikely to add unmitigated risk. The draft lists the same elements without the AI-specific bias reference.
How to Develop and Submit a PCCP to the FDA
PCCP requirements have two layers: binding laws and regulations, and non-binding FDA recommendations on content.
Step 1: Define the scope of planned changes.
FDA recommends a few specific, verifiable modifications, not a list of every possible change. Scope reflects intended use, expected benefits, foreseeable risks, and the plan’s limits.
Step 2: Establish verification and acceptance criteria.
Criteria are set before implementation. FDA recommends verifying and validating the entire device after each modification and in aggregate. Evidence must fit the device and modification.
Step 3: Assess risks, benefits, and cumulative impacts.
The manufacturer’s existing quality system serves as the basis for the Impact Assessment.
Step 4: Integrate the PCCP into the marketing submission.
FDA recommends:
- A standalone section with a title and version number.
- Discussion in the cover letter and a table-of-contents entry titled “Predetermined Change Control Plan.”
- Cross-references from the device description and labeling.
- Public summaries (510(k) summary, SSED, or De Novo decision summary) that describe the PCCP.
If deficiencies remain unresolved, FDA may authorize the device upon withdrawal of the PCCP. Submission expectations differ by 510(k), De Novo, and PMA, so the matching section of the guidance should be checked.
Step 5: Use the Q-Submission Program where appropriate.
FDA encourages Q-Submission feedback on scope, evidence, and automatic updates before the marketing submission. This is especially useful for high-risk, life-sustaining, or implantable devices and combination products. FDA does not authorize a PCCP in a Pre-Submission.
How to Implement and Maintain an Authorized PCCP
Authorization is the starting point. FDA expects manufacturers to follow the plan and requires them to follow applicable legal requirements.
Execute the Authorized Protocol
Manufacturers should:
- Confirm the change is in the Description of Modifications.
- Follow the Modification Protocol.
- Complete verification, validation, risk assessment, and acceptance checks.
- Document the change and analysis under the quality system.
- Escalate any change that is not specified in the plan or not made per the protocol.
Maintain Records, Traceability, and Version Control
FDA’s quality system regulation (21 CFR Part 820) became the Quality Management System Regulation on February 2, 2026, incorporating ISO 13485:2016 .
Practical records include:
- Which modification was made.
- Which protocol and acceptance criteria were applied.
- Testing and risk assessments performed.
- Reviewer approvals.
- Affected versions.
- The conclusion on consistency with the plan.
New UDIs are required for a new version or model of a device that must bear a UDI.
Manage Labeling and Postmarket Monitoring
FDA recommends labeling that states the device has an authorized PCCP, updated as the plan specifies. It anticipates monitoring of safety and performance as modifications are implemented. General obligations, such as medical device reporting under 21 CFR Part 803, apply regardless of a PCCP. Statutory notification requirements apply only if FDA imposes them.
Determine When Changes Require a New Marketing Submission
FDA postmarket modifications outside the plan are evaluated under the applicable requirements and FDA’s Device Modifications guidances. A modification included in the PCCP but not implemented per the protocol will likely need a new submission. The new submission may seek authorization of a modified PCCP, the modified device, or both. The submission type depends on the device, its route to market, and the change. For De Novo-classified devices, the classification regulation and special controls also matter.
FDA PCCP Examples and Case Studies
FDA-Authorized Device Examples
Both verified examples come from FDA 510(k) records and show that FDA cleared a PCCP with the device.
- Canvas Dx (Cognoa, Inc.), K243558, decision letter dated April 11, 2025. This is a machine-learning aid for autism diagnosis in ages 18-72 months. The PCCP covers decision-threshold optimization, model retraining, and addition of questionnaire-based features within limits.
- RelieVRx (Pico G3) (AppliedVR), K251519, decision letter dated August 13, 2025. The 510(k) was submitted to add a PCCP for future headset hardware changes. Intended use and therapeutic content are unchanged. The summary describes no AI function.
These records establish that FDA cleared the PCCP and describe its scope at summary level.
Common PCCP Compliance Challenges
- Overly broad modification descriptions. Broad wording makes the authorized scope hard to interpret. Descriptions should name affected functions, outcomes, boundaries, and limitations.
- Inadequate validation or acceptance criteria. Subjective criteria and mismatched evidence weaken a plan. Criteria should be predetermined, measurable, and scientifically justified.
- Insufficient assessment of cumulative changes. Individually acceptable changes can interact. Both individual and combined effects should be evaluated.
- Weak implementation controls and postmarket monitoring. Gaps in version control, review responsibilities, and real-world monitoring create risk. Controlled procedures, traceability, and escalation rules reduce it.
Conclusion
An FDA predetermined change control plan sets the scope and controls for specified future device modifications. It is not unrestricted permission to modify a device, and manufacturers must still keep evidence, traceability, and postmarket monitoring in place. Manufacturers should assess planned modifications early, verify the latest FDA guidance, and document how each change is judged against the authorized plan.
For support with PCCP planning, FDA submission preparation, or medical device change control, explore Artixio’s medical device regulatory services or contact our regulatory experts at info@artixio.com.
FAQs
Q1. Is a PCCP mandatory for medical device manufacturers?
No. Section 515C says FDA “may” approve or clear a PCCP, and the draft guidance states PCCPs are optional. Without one, manufacturers must still evaluate every change under 21 CFR 807.81(a)(3) or 814.39(a).
Q2. Can a PCCP eliminate the need for future 510(k) submissions?
No. It can remove the need for a new 510(k) for changes consistent with the authorized plan. Changes outside the plan are assessed under the usual rules, and modifying the PCCP itself generally needs a new submission.
Q3. Can non-AI medical devices use a PCCP?
Yes, within the statute. Section 515C is not limited to AI, and the draft guidance covers all device types but is still draft. The final guidance addresses AI-DSFs. FDA cleared a PCCP for hardware changes to a VR therapy device.
Q4. Can a PCCP cover changes to intended use?
Modifications must stay within intended use. FDA generally expects them to stay within indications for use. Some narrow indication changes may suit a PCCP, and FDA highly encourages Q-Submission discussion first.
Q5. Does an authorized PCCP permit implementation without further FDA review of each planned change?
For changes specified in the plan and implemented per the protocol, no new marketing submission is needed. The manufacturer must still follow the plan, document the change, and keep the device compliant. Deviations may make the device adulterated and misbranded.
Q6. What happens when a modification falls outside the authorized PCCP?
The manufacturer assesses it under applicable FDA requirements before implementation. A new submission may be needed for the modified device, a modified PCCP, or both.
