PCCPs for Devices: Planning Changes Before FDA Authorisation
Define planned changes, tests and labeling in the submission, then prove each release fits the authorised plan.
In Short
- In-plan changes skip a new 510(k).
- Out-of-plan: usual route applies.
- Post-plan versions aren't predicates.
Section 515C of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. 360e-4 and added in December 2022, lets FDA approve or clear a predetermined change control plan (PCCP) as part of a device's marketing submission. Changes made consistent with an authorised plan do not need a new PMA supplement or 510(k). PCCPs are often discussed for machine-learning software, but the statute covers devices generally. FDA's PCCP guidance documents were not opened for this guide. This is orientation, not legal advice. Sources checked 4 Oct 2026.
What the statute allows
For approved devices, 21 U.S.C. 360e-4(a) says a supplemental application is not required for a change consistent with an approved PCCP.
Approved vs Cleared Devices under 360e-4
| Pathway | Change consistent with plan | Condition |
|---|---|---|
| PMA (approved) | No supplement needed | Device remains safe and effective |
| 510(k) (cleared) | No new notification needed | Safe, effective and substantially equivalent |
| Change outside plan | Usual route applies | Regulatory team decides |
- PMA (approved)
- Change consistent with plan
- No supplement needed
- Condition
- Device remains safe and effective
- 510(k) (cleared)
- Change consistent with plan
- No new notification needed
- Condition
- Safe, effective and substantially equivalent
- Change outside plan
- Change consistent with plan
- Usual route applies
- Condition
- Regulatory team decides
More on what the statute allows
FDA may approve a plan that describes planned changes that would otherwise need a supplement, if the device remains safe and effective without any change. For cleared devices, subsection (b) says a new premarket notification is not required for a change consistent with a cleared plan, provided the device remains safe and effective and would remain substantially equivalent to the predicate. The plan is part of the authorisation, not a later side agreement.
What FDA can require in a plan
Under subsections (a)(3) and (b)(3), FDA may require a plan to include labeling required for safe and effective use as the device changes, notification requirements if the device does not function as intended under the plan, and performance requirements for changes made under it. In practice that means each planned change needs defined acceptance criteria, a verification and validation method, and a labeling update approach before submission.
More on what FDA can require in a plan
Changes outside the plan's description follow the usual supplement or 510(k) route; the plan does not widen itself.
The Predicate Rule
Subsection (c) limits how changed devices can be used as predicates. When FDA determines substantial equivalence, it shall not compare a device to versions changed under a PCCP as the predicate.
More on the Predicate Rule
Only the version cleared or approved before changes under the plan may be used. For a manufacturer this matters when planning a product family: a later 510(k) cannot rely on the post-PCCP performance of an earlier device as its predicate, so keep a clear record of which version was authorised and which versions resulted from the plan.
Worked Example: Plan Record PC-14
Illustrative only. A device software team records plan PC-14 inside its design history: three planned modification types, each with its own test protocol, acceptance criteria and labeling text to update.
Release check against plan PC-14 (illustrative)
More on worked Example: Plan Record PC-14
When release 2.3 is ready, engineering links the verification report, quality confirms the change matches modification type 2 and meets its criteria, and regulatory confirms no step falls outside the authorised description. Only then does the release proceed, with the device master record and labeling version updated. A change that fails the criteria returns to the normal premarket route.
Quality System Links
A PCCP does not remove design controls, change control or complaint handling under FDA's quality system requirements; it changes whether a new premarket submission is needed. Treat each implemented change as a controlled design change with its own records, and monitor field performance so the notification requirements in the plan can be met.
More on quality System Links
Decisions about whether a change fits the plan, and whether the device remains safe and effective, are made by qualified people. FDA's final guidance documents on PCCPs, including for AI-enabled software, add recommendations this guide did not review.
Questions
What is a predetermined change control plan?
A plan, authorised in a PMA or 510(k), describing planned device changes that can then be made without a new supplement or premarket notification, under 21 U.S.C. 360e-4.
Is a PCCP only for AI software?
No. The statute applies to devices generally. FDA has published guidance focused on AI-enabled software functions, which was not opened for this guide.
Can a device changed under a PCCP be a predicate?
No. Under subsection (c), only the version cleared or approved before changes under the plan may be used as a predicate.
What happens if a change falls outside the plan?
It is not covered by the PCCP, so the usual PMA supplement or 510(k) requirements apply. Your regulatory team decides the route.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
Australia Medical Device Regulatory Readiness Guide
Brazil medical device regulatory readiness guide (ANVISA)
Canada Medical Devices Regulations (SOR/98-282) Readiness
China Medical Device Regulatory Readiness Guide 2026
eDHR Implementation: A Medical-Device Rollout Guide
EU MDR medical device regulatory readiness (European Union)