Predetermined change control plans for medical devices
A predetermined change control plan, or PCCP, lets FDA review planned device changes up front, so each one does not need its own submission. This guide covers what a PCCP contains, which changes fit, a worked protocol outline, and where FDA, IMDRF, the UK and the EU stand.
How we got here
The three parts of a PCCP
FDA expects the same three parts in every PCCP. IMDRF and Health Canada use slightly different names for the same content.
Description of modifications
Each planned change, why you want it and its limits. Say whether it is manual or automatic, and global or site-specific.
Modification protocol
How each change is developed, tested and released. Data management, retraining, performance evaluation and update procedures, with acceptance criteria set in advance.
Impact assessment
Benefits and risks of each change and of all changes together, including unintended bias, and how the protocol controls them.
FDA recommends a limited number of specific changes that can be verified and validated, plus a traceability table that links each change to its protocol methods.
What fits in a PCCP
Every change must keep the device within its intended use and, for a 510k, substantially equivalent to the predicate. FDA's final AI guidance and its all-device draft give examples.
| Change | Fit | Source |
|---|---|---|
| Software and AI | ||
| Retraining on new data from the same intended population and input type | Usually fits | AI guidance |
| New sources of the same input type, such as another scanner make or model | Usually fits | AI guidance |
| Compatibility with new hardware, operating systems or cloud platforms | Usually fits | AI guidance |
| Limited new input types | PossiblyDiscuss in a Pre-Sub | AI guidance |
| Performance claims for a subgroup within the indicated population | PossiblyWith data for that subgroup | AI guidance |
| Use with an additional device or component | PossiblyDiscuss in a Pre-Sub | AI guidance |
| Automatic updates | PossiblyCase by case, with clear guardrails | AI guidance |
| Site or patient-specific adaptation | PossiblyWith the local factors defined | AI guidance |
| Any device | ||
| Design, labeling or manufacturing changes that stay within intended use and add no new risks | PossiblyChanges to existing risks need mitigations | All-device draft |
| For PMA devices, minor changes and manufacturing changes | Possibly | All-device draft |
| Usually needs a new submission | ||
| A change to intended use, or most changes to the indications for use | New submission | AI guidance |
| A new patient population, or a general to specific indication | New submission | All-device draft |
| Prescription to over the counter, or changing a contraindication | New submission | All-device draft |
| Single-use to reusable, or a new operating principle, control mechanism or energy type | New submission | All-device draft |
| Changes that need new clinical data, or that address a recall or safety issue | New submission | All-device draft |
| Leave out of the PCCP | ||
| Changes that would not need a new submission anyway | Leave outDocument them in your QMS | AI guidance |
Is a PCCP the right path?
Yes to the first three and low risk at the fourth. Raise it in a Pre-Sub.
A modification protocol, outlined
A 510k-cleared software device that flags suspected wrist fractures on radiographs for clinician review, with two planned changes.
| Protocol part | M1 · Retraining | M2 · New detectors |
|---|---|---|
| Data management | New cases from current and new US sites under the same inclusion criteria. Reference standard from three radiologists. Test set kept separate from training data. | Cases from each new detector make and model, labeled with the same reference standard method. |
| Retraining | Model weights and the operating threshold may change. Architecture and input size stay fixed. Triggered by a set number of new cases or by drift. | No retraining unless the performance gate fails. Preprocessing may change within stated ranges. |
| Performance evaluation | Sensitivity and specificity with 95% confidence intervals. Non-inferior to the cleared version and to the last released version. Subgroups by age, sex, site and detector. | The same endpoints for each detector make and model, each meeting the authorized performance specification. |
| Update procedures | Manual release after QA sign-off. New version number and UDI where required. Updated performance summary, release notes and in-app notice. Security testing and an updated SBOM. | The same, plus an updated list of compatible detectors in the labeling. |
| Impact assessment link | Lower specificity could raise false positives. Controlled by the specificity gate and subgroup review. | Image differences could lower accuracy. Controlled by per-detector testing. |
Read a real one
FDA lists authorized devices with PCCPs on its PCCP page, launched in October 2026.
What FDA asks for beyond the three parts
Labeling
Say the device has an authorized PCCP. As changes ship, describe each one, current performance and how users are told. Leave out changes that have not shipped.
Public summary
Your 510k summary or De Novo decision summary describes the planned changes, testing methods and how users are informed.
Its own section
A standalone PCCP with a title and version number, flagged in the cover letter and in eSTAR.
Predicates
Until a later 510k clears the changed device, only the version cleared before any PCCP changes can serve as a predicate.
Deviations
A change that skipped the protocol or failed its criteria can make the device adulterated and misbranded. Record the failure and do not release it.
Quality system
Each change still runs through design change control. Keep the records for every version.
Outside the US
Other regulators are building similar routes. IMDRF N90 sets shared principles for software PCCPs, with the same three parts under slightly different names.
Where a route does not exist yet, plan the change process in your technical documentation and expect a separate review in each market.
| Regulator | Status | Note |
|---|---|---|
| IMDRF N90 | Final 2026 | Software only. Five principles and three elements. |
| Health Canada | In place | Machine learning device guidance, final Feb 2025, accepts PCCPs. |
| United Kingdom | Planned | No PCCP route yet. MHRA plans draft guidance by Dec 2026. |
| European Union | Proposed | No PCCP route in the MDR today. A Dec 2025 Commission proposal would add one. |
Submission checklist
Start from the Cosm PCCP template
A Word template built around the three parts of a PCCP covered in this guide.
Questions
Q01Is a PCCP required?
No. A PCCP is optional. It makes sense when you expect to repeat a type of change after clearance and can define and test it in advance.
Q02Is FDA's PCCP guidance final?
The guidance for AI-enabled device software functions is final. FDA issued it in December 2024 and reissued it in August 2025. The broader guidance for all devices is still the August 2024 draft, and CDRH lists it as a guidance it plans to finalize in fiscal 2027.
Q03Which submissions can include a PCCP?
510k submissions, De Novo requests and PMA applications, including certain PMA supplements. A Special 510k is generally not the route to set up a new PCCP, though it may work to modify one. FDA does not authorize a PCCP in a Pre-Sub.
Q04Can we change a PCCP after it is authorized?
Generally only through a new marketing submission that includes the revised PCCP. FDA asks for a summary of the changes and a tracked-changes copy.
Q05Can a PCCP cover continuous learning?
FDA considers automatic updates case by case and expects clear guardrails on what can change. Discuss them in a Pre-Sub before you file.
Q06What if a planned change fails its acceptance criteria?
Do not release it, and record the failure. Releasing a change that did not follow the protocol or meet its criteria is a deviation.
Q07Do users need to be told about changes made under a PCCP?
Yes. Labeling should say the device has an authorized PCCP and describe each change that ships and how users are informed, such as a version history or release notes.
Q08Does the EU accept PCCPs?
Not under the MDR today. The Commission's December 2025 proposal to revise the MDR and IVDR would add one. The AI Act already treats changes set out at the initial conformity assessment as not a substantial modification.
General information, not legal or regulatory advice.
Sources · FD&C Act section 515C · FDA, Marketing Submission Recommendations for a PCCP for AI-Enabled Device Software Functions (Aug 18, 2025, first issued Dec 4, 2024) · FDA, Predetermined Change Control Plans for Medical Devices, draft (Aug 22, 2024) · FDA, Predetermined Change Control Plans web page and list of authorized devices (Oct 20, 2026) · FDA, Health Canada and MHRA, PCCP Guiding Principles (Oct 2023) · 21 CFR 892.2055 (91 FR 36522, Jun 17, 2026) · IMDRF N90 (2026) · Health Canada, Pre-market guidance for machine learning-enabled medical devices (Feb 2025, updated Apr 2026) · MHRA, Government response on AI in healthcare (Oct 6, 2026) · European Commission, COM(2025) 1023 (Dec 16, 2025) · Regulation (EU) 2024/1689, Article 43(4)
