The guidance is still draft, but PCCPs are already usable
FDA issued the draft guidance Predetermined Change Control Plans for Medical Devices in August 2024. As of August 2026, FDA still lists the document as draft and not for implementation.
That status does not mean manufacturers must wait before using a PCCP. Section 515C of the Federal Food, Drug, and Cosmetic Act is already in effect and self-executing. FDA has stated that manufacturers may submit a PCCP now and that FDA may approve or clear one as part of an applicable device marketing submission.
The draft guidance applies broadly to devices, including device-led combination products, reviewed through the 510(k), De Novo, and PMA pathways.
What a PCCP is intended to do
A PCCP allows a manufacturer to identify certain future device modifications in advance and submit the planned modifications, the methods that will be used to develop and validate them, and an assessment of their potential impact for FDA review.
When a modification is implemented in accordance with an FDA-authorized PCCP, the manufacturer may avoid a separate marketing submission for each modification already described and authorized in that PCCP.
This does not make future changes unrestricted. The modification must remain within the scope of the authorized PCCP and be implemented using the methods and controls FDA reviewed.
The three core elements FDA expects
Description of Modifications
The PCCP should identify the specific modifications the manufacturer intends to make in the future. The draft guidance emphasizes enough detail for FDA to understand the scope of the planned changes rather than relying on broad descriptions such as general performance improvements or software updates.
Modification Protocol
The manufacturer should describe how each planned modification will be developed, validated, and implemented. This includes the testing approach, acceptance criteria, and other methods used to demonstrate that the modified device continues to meet applicable requirements.
Impact Assessment
The PCCP should assess how the proposed modifications could affect the device, including safety and effectiveness, and explain why the proposed verification and validation activities are appropriate to manage those effects.
Which future modifications may fit a PCCP
The draft guidance also discusses how manufacturers should determine whether a proposed modification is appropriate for inclusion in a PCCP.
A useful way to think about the proposed framework is that a modification should be foreseeable enough to describe prospectively, bounded enough for its impact to be evaluated, and supported by validation methods that can be defined before the modification occurs.
A PCCP is therefore not a mechanism for placing every possible future device change under a single authorization.
What manufacturers can examine now
For products with frequent lifecycle changes, manufacturers can start by asking:
- Which modifications are already reasonably foreseeable over the next several years?
- Can those modifications be described with enough specificity at the time of the marketing submission?
- Can verification and validation methods and acceptance criteria be defined before the modification occurs?
- Does the change-control system ensure that implementation remains within the scope of the authorized PCCP?
- If the device contains AI-enabled device software functions, does the proposed PCCP also need to be evaluated against FDA’s final AI-specific PCCP guidance?
The regulatory value of a PCCP is not that a manufacturer can make unrestricted future changes. It is that certain predictable changes can be reviewed earlier as part of a lifecycle strategy, potentially reducing the need for repeated marketing submissions when those authorized modifications are later implemented.
Sources
- Primary official sourcePredetermined Change Control Plans for Medical Devices (opens in a new tab)U.S. Food and Drug Administration
- Supporting sourcePredetermined Change Control Plans for Medical Devices (opens in a new tab)U.S. Food and Drug Administration
- Supporting sourcePredetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability (opens in a new tab)Office of the Federal Register
- Supporting sourceWebinar - Draft Guidance: Predetermined Change Control Plans for Medical Devices (opens in a new tab)U.S. Food and Drug Administration