Regulayer™ / The 156 laws / Pharma & life sciences
FDA · PCCP (AI device change control)
Predetermined Change Control Plan evidence.
What the signed record shows
The proof is a signed, tamper-evident record. Anyone can check it, 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
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.
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Part of the Regulayer™ proof catalogue: 156 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.