This extract comes from Predetermined Change Control Plans (PCCPs) for Medical Devices: A Practical Guide, the third booklet in our Regulatory Booklet Series. The series explores the core regulatory requirements medical device companies need to understand when developing new products.
If you work with medical devices, it’s almost guaranteed that the devices you build today will need improvements down the line. Updates happen, algorithms improve, and user needs evolve. To help streamline this process — and to spare companies from having to seek new clearance every time an update rolls out — the FDA introduced the Predetermined Change Control Plan, or PCCP.
A PCCP is, at its core, a preagreed plan for future changes to a medical device. Normally, certain modifications would require a fresh FDA marketing submission — most commonly a 510(k), a PMA, or a De Novo submission:
510(k) is the pathway most commonly used for moderaterisk (Class II) devices. To get clearance, a company must show the device is substantially equivalent to another legally marketed device.
MA (Premarket Approval) is the FDA’s most stringent review pathway, used for highrisk (Class III) devices. It requires extensive clinical and technical evidence demonstrating safety and effectiveness.
With a PCCP, a company can map specific, clearly defined updates they plan to make later — along with the testing and data that will support those updates. These are changes that would otherwise generally require an FDA submission. Once the FDA approves that plan, future changes that fall within the boundaries of the PCCP can occur without requiring the filing of a new 510(k), PMA, or De Novo each time.
It’s important to note that a PCCP does not eliminate the need for future FDA submissions altogether. Modifications outside the scope of the PCCP — or changes that fundamentally alter the device’s intended use, performance, or risk profile — will still require a new submission. Additionally, some minor or lowrisk modifications may not require an FDA submission at all and would not typically be included in a PCCP.
This approach is especially useful for products that evolve quickly — such as Software as a Medical Device (SaMD), connected devices, and those containing AI or machine learning. These products are iterated upon frequently, and a PCCP helps ensure the regulatory process doesn’t hinder responsible improvement.
At a high level, a solid PCCP covers:
Scope of changes
What types of updates you intend to make — algorithm tweaks, datamodel updates, performance refinements, or other predictable modifications.
Change protocols
How updates will be made safely and consistently. This includes internal processes, quality controls, and how you’ll manage data and documentation.
Verification & validation plans (V&V)
How each planned change will be tested, validated, and recorded so the FDA can be confident the device will still perform as expected.
At its core, a PCCP must include:
The planned modifications to the device
The risk analysis for those modifications
The verification and validation activities you’ll perform