A PCCP change leaves no new record

A cleared 510(k) has always meant the same thing going forward: the device FDA reviewed is the device on the market, until a change big enough to affect safety or effectiveness sends the applicant back for a new clearance. For a growing set of AI-enabled devices, that is no longer true. FDA can now pre-approve the next several versions of a device before any of them exist, and the record that later shows the device cleared never says which ones already shipped.

The statute behind the plan

Section 3308 of the Food and Drug Omnibus Reform Act of 2022 (FDORA) — Division FF of the Consolidated Appropriations Act, 2023, enacted December 29, 2022 — added a new Section 515C to the FD&C Act, codified at 21 U.S.C. § 360e-4. It lets FDA approve or clear a Predetermined Change Control Plan (PCCP) inside a 510(k), De Novo request, or PMA: a description of specific future modifications, and how they will be validated, submitted up front. Once FDA authorizes the plan, a change that matches it does not need the supplemental application or new 510(k) it would otherwise require.

What FDA actually reviews

FDA’s final guidance on the subject — effective December 2024, for AI-enabled device software functions specifically — sets out three required pieces of a PCCP: a Description of Modifications naming what will change, a Modification Protocol describing how each change will be developed and verified, and an Impact Assessment of what the plan means for the device’s benefits and risks. FDA reviews all three at clearance or approval, the same submission that reviews everything else about the device. The plan itself becomes part of the record FDA already keeps — the changes it authorizes have not happened yet.

A PCCP is not a promise to submit again later. It is FDA agreeing, once, to a version of the device that does not exist yet.

The record a change under the plan doesn’t create

When a manufacturer implements a change consistent with an authorized PCCP, Section 515C is explicit about what does not happen: no new 510(k), no new PMA supplement. Nothing about that decision requires a new K-number, a new decision code, or a new row in openFDA’s 510(k) dataset — the fields this blog has already read closely arek_number, decision_code, decision_date, and a handful of others fixed at the moment of the original clearance. FDA’s guidance directs manufacturers toward two places a PCCP and its implemented changes should actually be disclosed: the device’s labeling, and the 510(k) summary FDA posts under 21 CFR 807.92. Both are documents, not database fields. A predicate search built only from openFDA’s structured 510(k) record will not surface that a competitor’s cleared device has already changed twice since the day it cleared.

The practice

Watching a product code for “a competitor cleared” used to be watching for the event that mattered. For a device cleared with an authorized PCCP, the event that matters most — a materially different version reaching the market — can now happen with no new clearance event at all. Whether a specific competitor’s device carries an authorized PCCP, and what an implemented change under one means for a predicate or portfolio decision, is a judgment for the regulatory professional holding that file — this is regulatory intelligence and method, about where a change does and doesn’t leave a public trace, never regulatory advice about a submission of your own.

FDA Radar ingests k_number, decision code, product code, and decision date on every clearance exactly as openFDA publishes them; see what we monitor and how often. A PCCP flag isn’t missing from that record by omission. openFDA has never published a field for one.