Predetermined Change Control Plans: A Quick-Reference Summary

Predetermined Change Control Plans: A Quick-Reference Summary

A Predetermined Change Control Plan (PCCP) is a document, submitted as part of a 510(k), De Novo, or PMA, that describes the modifications a manufacturer anticipates making to an AI/ML device after authorization and the methodology used to implement and validate those changes without a new premarket submission for each one. FDA's guidance requires three core components: a description of planned modifications, a methodology for implementing and validating each one, and an impact assessment addressing safety and effectiveness.

A PCCP does not exist in isolation -- it is an extension of your device's software lifecycle documentation and Design Controls under 21 CFR 820.30, and it must be operationalized through your Quality Management System, not treated as a submission-day checkbox.

For the full picture of what a PCCP is, when your device needs one, and how it fits into your broader AI/ML regulatory strategy, see ADB's AI/ML SaMD regulatory strategy guide. If you've encountered FDA's older SaMD Pre-Specifications (SPS) / Algorithm Change Protocol (ACP) terminology, the "PCCP Terminology" section below maps it to the current framework.

PCCP for AI/ML Devices: A Quick-Reference Summary

A Predetermined Change Control Plan (PCCP) is a document submitted as part of an AI/ML device's 510(k), De Novo, or PMA that describes the modifications a manufacturer anticipates making to the device after authorization, along with the methodology used to implement and assesses those changes without a new premarket submission for each one. FDA's PCCP guidance requires three core components: a description of planned modifications, a modification protocol describing how each change will be tested and assessed, and an impact assessment evaluating the effect of those changes on safety and effectiveness.

A PCCP is not optional paperwork -- it is a binding part of your marketing authorization once cleared, and it must be operationalized through your Quality Management System under 21 CFR Part 820, not treated as a submission-day checkbox.

For the full picture of what a PCCP is, when your device needs one, and how it fits into your broader AI/ML regulatory strategy, see ADB's AI/ML SaMD regulatory strategy guide.

Where Does a PCCP Actually Live in Your Submission?

A Predetermined Change Control Plan (PCCP) is not a standalone filing -- it is a component embedded inside a 510(k), De Novo request, or PMA. But which one, and when in that submission's own process should it be raised with FDA? Those are the practical questions this post answers. For what a PCCP is, its three required components, and whether your device needs one at all, see ADB's AI/ML SaMD regulatory strategy guide.

Submission Strategy: Where Does the PCCP Live?

A PCCP can be included in an initial 510(k), De Novo, or PMA submission, or submitted as a supplement or amendment to an existing cleared or approved device. FDA recommends using a Q-Submission (pre-submission meeting) to align on scope before you invest significant resources in drafting -- particularly for novel AI architectures or adaptive learning systems that update at the point of care.

How Placement Changes the Bar You Have to Clear

If your device cleared as a 510(k) with a substantial equivalence predicate, your PCCP's Impact Assessment must show that the changes remain within the technological characteristics and intended use envelope of that clearance. For PMA devices, the bar is higher: you must affirmatively show that the modifications do not diminish reasonable assurance of safety and effectiveness. De Novo requestors get a third posture entirely -- there is no predicate to stay within, so FDA is evaluating whether your proposed special controls (with the PCCP as one of them) are sufficient on their own.

Under 21 CFR Part 820 and the quality system framework, any software change must still be evaluated under your design change procedures regardless of which pathway carries your PCCP. A PCCP does not eliminate your QMS obligations -- it pre-authorizes specific, bounded changes at the regulatory submission level, provided your internal change controls are executed as described.

The Bottom Line

A well-executed PCCP is a competitive asset, not just a compliance exercise. It shortens your post-market iteration cycle, reduces regulatory unpredictability, and signals to FDA -- and to investors -- that your organization understands how to govern AI responsibly. But it requires precise drafting, deep integration with your quality system, and a realistic risk analysis that reflects your actual development pipeline.

At ADB Consulting & CRO Inc., Andre Butler and the team work directly with AI/ML device manufacturers to develop PCCPs that are technically rigorous and strategically aligned with your go-to-market timeline. Whether you are preparing an initial submission or retrofitting a PCCP onto an existing cleared device, we can help you get it right the first time.

Ready to build a PCCP that stands up to FDA review? Book a free discovery call with our team at adbccro.com and let's map out your regulatory strategy today.

Why PCCP Terminology Gets Confusing Fast

If you spend time in FDA's earlier AI/ML discussion papers, you'll run into terms that no longer appear in the current Predetermined Change Control Plan (PCCP) framework -- most notably SaMD Pre-Specifications (SPS) and the Algorithm Change Protocol (ACP). Regulatory teams referencing older FDA materials, consultants trained on the 2019 discussion paper, or reviewers who cut their teeth on the earlier framework will still reach for this vocabulary, even though current PCCP guidance reorganizes the same underlying concepts under different section names. Knowing how the old maps to the new keeps your team, your consultants, and your reviewers speaking the same language. For what a PCCP requires today and whether your device needs one, see ADB's AI/ML SaMD regulatory strategy guide.

The Regulatory Foundation: What Authorizes PCCPs

PCCPs were formally authorized under Section 3308 of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which amended Section 515C of the Federal Food, Drug, and Cosmetic Act. FDA followed up with its final guidance, 'Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions,' finalized in December 2024. This guidance is your primary reference document -- not optional reading.

PCCPs are currently applicable to AI/ML-enabled Device Software Functions (AI/ML DSF) submitted via 510(k), De Novo, or PMA pathways. The PCCP, once approved as part of your marketing submission, allows you to implement defined modifications without submitting a new 510(k) or PMA supplement for each change, provided those modifications stay within the boundaries you defined upfront.

The Three Required Components of a Compliant PCCP

FDA's guidance is explicit about what a PCCP must contain. Missing or underdeveloped sections are among the most common reasons PCCPs receive a Not Substantially Equivalent determination or a Major Deficiency in PMA review. Every PCCP must include the following three elements:

1. Description of Modifications

This section defines the scope of what changes you are pre-authorizing. You must describe each planned modification with enough specificity that a reviewer can determine whether a future change falls inside or outside the PCCP's boundaries. Vague language like 'performance improvements' will not pass review. Instead, specify the type of modification -- for example, retraining on expanded demographic datasets to improve sensitivity in a defined subpopulation -- and articulate the upper bounds of that change. Think of this as writing a contract with FDA: precision protects you.

2. Modification Protocol

For each modification category described above, you must establish the specific methods and procedures you will use to implement and assesses the change. This includes your data management practices, algorithm retraining procedures, performance testing methodology, and how you will assess whether the modified device still meets its predicate or original performance specifications. Reference your Design Controls under 21 CFR Part 820.30 here -- your PCCP protocol should align directly with your Quality Management System procedures, particularly if you are also ISO 13485 certified.

3. Impact Assessment

This is where many sponsors underinvest. The impact assessment must address how each modification type affects safety and effectiveness, including any changes to the device's risk profile. Reference your risk management file and align this section with ISO 14971 principles. FDA will scrutinize whether you have considered performance across subpopulations, potential failure modes introduced by retraining, and any cybersecurity implications of updated model files -- particularly relevant under FDA's 2023 cybersecurity guidance for device submissions.

Common Drafting Mistakes That Trigger FDA Deficiencies

• Scope creep in modification descriptions: Describing modifications so broadly that FDA cannot establish a reviewable boundary. Specificity is not a weakness -- it is what makes a PCCP approvable.
• Disconnected performance metrics: The performance thresholds in your modification protocol must match the predicate performance claims in your 510(k) or the approved specifications in your PMA. Inconsistency signals that your QMS is not integrated with your regulatory strategy.
• Ignoring the SaMD Pre-Specs and Algorithm Change Protocol legacy framework: FDA's 2019 discussion paper on AI/ML-based SaMD introduced the SaMD Pre-Specifications (SPS) and Algorithm Change Protocol (ACP) concepts. While the PCCP framework supersedes this for formal submissions, reviewers still think in terms of these concepts. Structuring your PCCP with this mental model will produce a cleaner, more reviewable document.
• Failing to address real-world performance monitoring: A PCCP without a post-deployment monitoring plan will raise red flags. Describe how you will detect performance drift in the field and how that data feeds back into your modification protocol triggers.

Strategic Considerations: When to Include a PCCP

Not every AI/ML device needs a PCCP at initial submission. If your algorithm is truly locked and you have no near-term plans to retrain it, adding a PCCP can introduce unnecessary complexity and scope into your submission. However, if your commercial strategy depends on continuous learning, expanded indications, or improving performance post-clearance, not including a PCCP means every meaningful update triggers a new submission -- a significant competitive disadvantage.

For De Novo applicants in particular, a well-constructed PCCP can be a differentiator. It signals to FDA that your organization has mature change management processes, which can positively influence reviewer confidence in your overall submission package.

Aligning Your PCCP With Your Quality System

A PCCP is not a standalone document -- it is a commitment that must be operationalized through your Quality Management System. Under 21 CFR Part 820 (and the updated Quality System Regulation aligned with ISO 13485), your CAPA procedures, design change controls, and software validation protocols must be capable of executing every protocol you describe in the PCCP. If your QMS cannot support the promises in your PCCP, you have a compliance gap that FDA will eventually find -- either at submission review or during a facility inspection.

Ready to Build a PCCP That Gets Approved?

At ADB Consulting and CRO Inc., we work with AI/ML device companies at every stage -- from pre-submission strategy through post-market compliance -- to build regulatory submissions that move forward, not sideways. Andre Butler and the ADB team have hands-on experience drafting PCCPs across multiple device classifications and FDA submission types.

If you are preparing an AI/ML device submission and want to get your PCCP right the first time, book a free discovery call with our team at adbccro.com. We will assess your current documentation, identify gaps, and give you a clear path forward -- no generic advice, no wasted time.

What FDA Reviewers Are Actually Scoring in Your PCCP

A Predetermined Change Control Plan (PCCP) doesn't get evaluated as a single pass/fail document -- FDA reviewers work through it against a specific evaluation lens, checking each section against a distinct question. Understanding that lens, not just the PCCP's required components, is what separates a plan that clears review from one that draws a deficiency letter. For the full background on what a PCCP is and when your device needs one, see ADB's AI/ML SaMD regulatory strategy guide.

This post breaks down the specific checkpoints FDA reviewers apply to each PCCP section -- not just what the guidance says you must include, but what a reviewer is actually testing for when they read it.

What Is a PCCP and Where Does the Authority Come From?

A Predetermined Change Control Plan is a document -- submitted as part of a 510(k), De Novo, or PMA -- that describes modifications a manufacturer anticipates making to an AI/ML device after authorization, along with the methodology used to implement and assesses those changes without requiring a new premarket submission each time.

The statutory authority for PCCPs was codified under Section 3308 of the Food and Drug Omnibus Reform Act (FDORA) of 2022, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding Section 515C. This legislation directed FDA to issue guidance on PCCPs, which materialized in the agency's January 2025 final guidance: 'Predetermined Change Control Plans for Artificial Intelligence-Enabled Devices.'

This final guidance supersedes the draft guidance issued in April 2023 and represents FDA's current, enforceable thinking. If your regulatory strategy is still based on the 2023 draft, you need to update it now.

The Three Core Components FDA Expects in Your PCCP

FDA's final guidance identifies three foundational elements that every PCCP must address. Weak execution on any one of these is enough to trigger a substantive deficiency letter or an outright refusal to accept.

1. Description of Planned Modifications

You must clearly articulate what types of changes are anticipated. This is not a wish list -- it is a scoped, bounded description of modification types, such as retraining the algorithm on expanded datasets, updating performance thresholds, or modifying the intended patient population. Vague language like 'improvements to model performance' will not survive FDA review. Each modification type must be specific enough that a reviewer can understand exactly what is and is not included.

2. Modification Protocol

This is the technical heart of the PCCP. The modification protocol must describe the specific methods, datasets, testing procedures, and performance benchmarks that will govern each planned change. FDA expects you to define your training, tuning, and test dataset requirements; your statistical performance metrics; and the acceptable performance boundaries that, if crossed, would trigger a new submission rather than PCCP implementation. Reference to recognized consensus standards, such as those from ANSI/AAMI or ISO 13485:2016 quality system requirements, strengthens the credibility of your protocol.

3. Impact Assessment

You must demonstrate that you have systematically evaluated the risks introduced by each modification type. This includes changes to device safety, effectiveness, and -- critically -- any potential for introducing or amplifying algorithmic bias. FDA has been explicit in its guidance that health equity considerations are part of a credible impact assessment. Ignoring this will draw scrutiny.

PCCP and Your Quality System: The 21 CFR Part 820 Connection

A PCCP does not exist in a vacuum. FDA expects the change management activities described in your PCCP to be embedded in your Quality Management System. Under 21 CFR Part 820 (now aligned with ISO 13485 through the 2024 Quality System Regulation update), your design controls, CAPA procedures, and post-market surveillance activities must be structured to support PCCP execution. If your QMS cannot generate the data outputs your modification protocol requires -- things like real-world performance metrics, adverse event signals, or dataset drift indicators -- your PCCP is aspirational at best and non-compliant at worst.

Common Mistakes That Sink PCCPs at Submission

• Scope creep in the modification description: Trying to cover every conceivable future change makes the PCCP unmanageable and signals to FDA that you lack disciplined development governance.
• Undefined performance boundaries: If you do not specify the quantitative thresholds that trigger a new submission, FDA has no way to confirm your device will remain safe and effective after a change.
• Disconnected from clinical validation: Changes to an AI/ML device often affect clinical performance. Your PCCP must address how clinical validity will be reassessed under the modification protocol, especially for higher-risk devices under PMA.
• Treating the PCCP as a submission checkbox: FDA will evaluate PCCP compliance during inspections. Manufacturers who draft a PCCP for submission and then ignore it operationally are creating significant regulatory exposure.

Start Early, Build Strategically

The companies that succeed with PCCPs are the ones that begin the planning process during design and development -- not during submission prep. The decisions you make about model architecture, dataset governance, and performance metrics early in development directly determine how robust your PCCP can be. Retrofitting a PCCP onto a poorly documented development history is painful, expensive, and often unconvincing to FDA reviewers.

At ADB Consulting and CRO Inc., Andre Butler and the team work directly with medical device startups and established manufacturers to build regulatory strategies that treat the PCCP as a competitive asset, not a bureaucratic hurdle. Getting this right the first time reduces submission cycles, protects your post-market flexibility, and positions your device for the kind of iterative improvement that AI/ML technology demands.

If you are preparing a 510(k), De Novo, or PMA for an AI/ML device -- or if you already have a cleared device and need to build a PCCP for future modifications -- now is the time to get expert eyes on your strategy.

Book a free discovery call with Andre Butler at adbccro.com to discuss your specific device, your submission timeline, and what a compliant PCCP looks like for your program. Do not let regulatory uncertainty slow down your innovation.

Why the PCCP Is Now a Strategic Imperative for AI/ML Device Makers

If your company is developing an artificial intelligence or machine learning-based Software as a Medical Device (AI/ML SaMD), you already know the core regulatory tension: your algorithm is designed to learn and improve over time, but FDA's traditional change control framework was built for static devices. Every meaningful algorithm update could theoretically trigger a new 510(k), PMA supplement, or De Novo submission -- creating a cycle that kills your product's competitive advantage before it ever reaches patients.

The Predetermined Change Control Plan (PCCP) is FDA's answer to this problem. Used correctly, it is one of the most powerful regulatory tools available to AI/ML device developers today. Used incorrectly -- or ignored entirely -- it can become a costly compliance liability.

This post lays out the PCCP's regulatory blueprint end to end. For a broader look at how AI/ML SaMD is classified, adaptive-vs-locked algorithm strategy, and GMLP expectations beyond the PCCP itself, see ADB's AI/ML SaMD regulatory strategy guide.

What Is a PCCP and Where Does It Live in the Regulatory Framework?

A PCCP is a documented plan, submitted as part of a marketing submission, that describes anticipated future modifications to an AI/ML device and the methodology by which those modifications will be implemented, assessed, and monitored -- without requiring a new premarket submission for each change.

The statutory authority for PCCPs was formalized under Section 3308 of the Food and Drug Omnibus Reform Act (FDORA) of 2022, which amended Section 515C of the Federal Food, Drug, and Cosmetic Act. FDA subsequently issued its final guidance, 'Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions,' finalized in December 2024. This guidance is the governing document your regulatory team must be working from today.

PCCPs can be included in 510(k), PMA, De Novo, and Humanitarian Device Exemption (HDE) submissions, as well as supplements to previously approved applications. The plan travels with the device's authorization -- meaning once FDA approves your PCCP, you have a pre-negotiated runway for iterative development.

The Three Core Components FDA Expects to See

FDA's guidance outlines a clear structure. A well-constructed PCCP must include three substantive elements:

• Description of Planned Modifications: You must clearly articulate the specific types of changes anticipated -- such as retraining on expanded datasets, changes to model architecture, or updates to intended use populations. Vague language like 'performance improvements' will not satisfy FDA reviewers. Be specific about the scope and boundaries of each modification type.
• Modification Protocol: This is the technical and procedural heart of your PCCP. It must describe the data management practices, retraining procedures, performance evaluation methods, and statistical validation approaches you will use to implement each planned modification. Your protocol should reference recognized standards where applicable, including ISO 13485 quality management requirements and relevant IEC 62304 software lifecycle processes.
• Impact Assessment: For each planned modification, you must demonstrate that you have evaluated the potential impact on device safety and effectiveness. This includes an analysis of how the change could affect algorithm performance, introduce new failure modes, or shift the benefit-risk profile for the intended patient population.

Common Mistakes That Get PCCPs Rejected or Flagged

Having reviewed and supported numerous AI/ML submissions, ADB Consulting sees the same patterns repeatedly derail otherwise strong PCCP packages:

• Overly broad modification scope: Attempting to cover every possible future change under a single PCCP umbrella signals to FDA that you have not conducted rigorous upfront risk analysis. Reviewers will push back.
• Weak SaMD Risk Categorization: Your PCCP must be calibrated to your device's risk level under the SaMD risk framework. A Class II diagnostic tool and a Class III treatment-influencing algorithm carry fundamentally different PCCP expectations. Applying a one-size-fits-all template is a red flag.
• Missing performance thresholds: Your modification protocol must include objective, pre-specified performance benchmarks -- not subjective language like 'acceptable performance.' FDA expects quantitative criteria tied to clinically meaningful endpoints.
• Disconnected post-market surveillance plan: A PCCP does not eliminate post-market obligations; it integrates with them. Your Real-World Performance Monitoring plan must be explicitly linked to your PCCP, showing how field data will trigger or constrain future modifications. This aligns with FDA's broader emphasis on 21 CFR Part 820 quality system requirements and the 2023 AI/ML Action Plan commitments.

Integrating the PCCP Into Your Regulatory Strategy Early

The single most expensive mistake a startup can make is treating the PCCP as a late-stage add-on. The modification boundaries you define in your PCCP directly shape your device architecture, your clinical and analytical validation study design, and your quality system infrastructure. If those decisions have already been locked in without PCCP considerations, retrofitting compliance becomes an expensive and time-consuming exercise.

Smart companies are building PCCP strategy into their design history file (DHF) structure from day one -- mapping anticipated algorithm lifecycle phases against regulatory touchpoints before a single line of production code is written. This is where experienced regulatory counsel pays for itself many times over.

What Comes Next for PCCP Regulation

FDA has signaled continued evolution in this space. The agency's ongoing work through the Digital Health Center of Excellence and the Total Product Life Cycle (TPLC) framework will further refine expectations for AI/ML transparency, bias monitoring, and real-world algorithm performance reporting. Companies that build adaptable, well-documented PCCPs today are positioning themselves favorably for the regulatory environment of the next five years.

Ready to Build a PCCP That Actually Holds Up to FDA Review?

At ADB Consulting and CRO Inc., Andre Butler and the team have deep hands-on experience developing AI/ML regulatory strategies and preparing PCCP packages that align with FDA expectations -- not just checkbox compliance. Whether you are preparing your first 510(k) for an AI-enabled device or filing a PMA supplement with a PCCP component, we bring the technical and regulatory depth to do it right the first time.

Book your free discovery call today at adbccro.com and let us help you turn your AI/ML innovation into a compliant, market-ready product.

Timing Your PCCP in the FDA Submission Sequence

Most AI/ML device teams treat the Predetermined Change Control Plan (PCCP) as a document to draft once the rest of the submission is nearly finished. That sequencing is backwards, and it is one of the most common reasons a PCCP arrives underdeveloped. The question this post answers is narrow but consequential: at what point in your regulatory timeline should PCCP work actually start, and what happens to your submission if you wait too long? For what a PCCP is and whether your device needs one at all, see ADB's AI/ML SaMD regulatory strategy guide.

Used correctly, the PCCP is a genuine competitive advantage. Used incorrectly, it creates a compliance gap that can trigger enforcement action or force a costly re-submission. Here is where PCCP work actually belongs in your submission sequence.

The Regulatory Foundation: What the Law Actually Says

Section 3308 of the Consolidated Appropriations Act of 2023 amended the Federal Food, Drug, and Cosmetic Act to explicitly authorize PCCPs as part of a marketing submission. This was a significant shift -- previously, FDA had only addressed the concept in its 2019 discussion paper and the 2021 AI/ML-Based SaMD Action Plan.

Under the statutory framework, a PCCP must include three core components:

• Description of Modifications: A precise, bounded description of the types of changes the manufacturer anticipates making to the device.
• Modification Protocol: The specific methods, validation procedures, and performance testing the manufacturer will follow before implementing each change.
• Impact Assessment: An analysis of how the proposed modifications and the protocol itself affect the device's safety and effectiveness profile.

FDA's January 2025 guidance elaborates substantially on each element and is now the primary reference document for any team drafting a PCCP. If your regulatory team is not working directly from that guidance, stop and reorient your effort around it.

What Modifications Can -- and Cannot -- Be Covered

One of the most common mistakes startups make is drafting a PCCP that is either too vague to be accepted or too broad in scope. FDA is explicit: a PCCP cannot be used to pre-authorize modifications that would change the intended use of the device, introduce new risks not assessed in the original submission, or alter the device's fundamental technology in ways that would require independent safety and effectiveness review.

Modifications that are generally appropriate for PCCP coverage include:

• Performance improvements to an existing algorithm driven by additional training data from the same patient population and clinical context
• Updates to model architecture that do not change the device's indications for use or output interpretation
• Expansion of demographic or imaging subgroups that fall within the originally cleared intended use
• Retraining schedules with pre-specified performance thresholds and drift-detection criteria

Modifications that require a new or supplemental marketing submission -- regardless of how your PCCP is written -- include changes to indications for use, changes to the device's risk classification, and modifications that introduce cybersecurity vulnerabilities or alter predicate reliance in a material way.

Building a Modification Protocol That Will Survive FDA Review

The modification protocol is where most PCCP submissions succeed or fail. FDA reviewers are looking for specificity, rigor, and transparency. A protocol that reads like a general quality management procedure will not satisfy the requirement.

Your modification protocol should define:

• Pre-specified performance metrics (sensitivity, specificity, AUC, or task-specific measures) with quantitative acceptance criteria
• The datasets to be used for validation, including diversity and representativeness requirements aligned with FDA's 2024 guidance on AI/ML transparency
• Statistical methods for demonstrating that post-change performance is non-inferior to the cleared version
• Real-world performance monitoring methods under 21 CFR Part 820 post-market surveillance obligations
• Clear stop criteria that trigger escalation to a formal FDA submission if a proposed change falls outside the PCCP's defined scope

Your Design History File and Risk Management File under ISO 14971 should be structured to accommodate iterative updates, because every PCCP-authorized change still generates design change documentation under 21 CFR 820.30.

Practical Submission Strategy: Where the PCCP Fits

For 510(k) submitters, the PCCP is included as a standalone section within the submission, and FDA will review it concurrently with the primary clearance review. For De Novo requestors, the same structure applies. PMA holders can include a PCCP in an original PMA or in a PMA supplement.

One strategic point that is often overlooked: FDA can reject or condition a PCCP independently of the primary device review. A weak PCCP can delay your overall clearance timeline even if the core device data is solid. Treat the PCCP as a first-class regulatory deliverable, not an appendix.

Start with a Pre-Submission Meeting

If your AI/ML device is heading toward a marketing submission and you are planning to include a PCCP, a Pre-Sub meeting with FDA is not optional -- it is essential. Use the Pre-Sub to align on the scope of your modification descriptions, the adequacy of your validation framework, and FDA's expectations for your specific device type and risk classification. The feedback you receive will save months of back-and-forth during formal review.

At ADB Consulting and CRO Inc., we have helped AI/ML device companies structure PCCPs that satisfy FDA reviewers while giving development teams the operational flexibility they actually need. Whether you are drafting your first Pre-Sub request or rebuilding a rejected PCCP, the regulatory pathway is navigable -- but only if your documentation strategy is built on a precise understanding of what FDA requires.

Ready to get your PCCP strategy right the first time? Book a free discovery call with Andre Butler and the ADB Consulting team at adbccro.com. We will review your device classification, intended use, and AI/ML architecture to give you a concrete roadmap -- no generic advice, no wasted time.