What does FDA · PCCP (AI device change control) cover?

Predetermined Change Control Plan evidence. It applies to: AI-enabled medical-device makers (US).

What does the Regulayer pack for FDA · PCCP (AI device change control) prove?

Change records traceable to a cleared PCCP · modification, protocol-conformance, and impact notes. The record is signed and tamper-evident, and anyone can verify it free, without an account.

Regulayer / The 146 laws / Pharma & life sciences

FDA · PCCP (AI device change control)

Predetermined Change Control Plan evidence.

Instrument: Regulatory guidance, nonbindingApplies to: AI-enabled medical-device makers (US). Built · guidance Dec 2024

What the signed record shows

Change records traceable to a cleared PCCP · modification, protocol-conformance, and impact notes.

The proof is a signed, tamper-evident record. Anyone can check it, free, without an account, and nothing has to leave the building to make it. Evidence, not a promise.

Citation: FD&C Act §515C (21 U.S.C. 360e-4); PCCP final guidance

In the same family

FDA · 21 CFR Part 11Electronic records & signatures EU GMP · Annex 11Computerised-systems integrity FDA-EMA · Good AI Practice (Jan 2026)Data governance, performance, life-cycle management

What to do about it

Keep the evidence this asks for, as the work happens.

A consequential AI-proposed action is checked against the human authority in force at that moment, and the decision leaves a signed record that a third party can verify independently, offline, without Regulayer. It runs inside your own environment and nothing has to leave it.

Life sciences: how the control works Or verify a real record, free →

Part of the Regulayer proof catalogue: 146 laws and standards, one sealed engine. This page is a product description, not legal advice.

What the statute requires, section by section

U.S. FDA Final Guidance, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions" (issued 4 December 2024; CDRH/CBER). Statutory hook: section 515C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-4), "Predetermined Change Control Plans for Devices", added by the Food and Drug Omnibus Reform Act of 2022 (FDORA). A PCCP has three interrelated components:

Description of Modifications: the specific, enumerated planned changes.
Modification Protocol: methods to develop, validate, verify and implement each modification.
Impact Assessment: documented benefit/risk analysis of each modification. Each implemented change must be traceable to a Description-of-Modifications entry and its Modification-Protocol step, with records that the device remained within the cleared PCCP. Applies to 510(k), De Novo and PMA pathways.

Taken from the Regulayer entry for this instrument, which is built against the primary text.