The FDA introduced the Predetermined Change Control Plan (PCCP) to ensure that changes to AI-enabled medical devices are carefully managed, assessed for safety and performance and comply with regulatory standards. It helps manufacturers proactively document and control changes, ensuring device functionality and patient safety are maintained over time.
Purpose of PCCP
The following are the key principles of PCCP
1. PCCP allows medical device manufacturers to define and document expected changes to their product, including updates to AI algorithms, data, or software functions.
2. It provides a structured process to document all modifications, ensuring a clear record of what has been changed, why and how it impacts the device.
3. Avoids the need for a separate 510(k) submission for each change, simplifying the approval process and reducing time-to-market.
4. This framework is designed to reduce the regulatory burden, particularly for AI/ML-based software as a medical device which often requires frequent updates. By implementing a Predetermined Change Control Plan (PCCP), manufacturers can streamline the approval process, ensuring that updates are efficiently managed without the need for separate regulatory submissions for each change.
What should be included in the Predetermined Change Control Plan (PCCP) for Medical Device
- Description & Justification of modifications
- Impact Assessment
- Modification Protocol
- Post-Change Monitoring Plans
Criteria for Including Modifications in PCCP
Modifications appropriate for inclusion in a PCCP include those intended to maintain or improve the safety or effectiveness of the device. Modifications should be specific and able to be verified and validated. Modifications included in a PCCP should maintain the device within its intended use, and, as applicable, must allow the device to remain substantially equivalent to the predicate device. Depending on the type of marketing authorization—PMA versus 510(k) and De Novo—different types of modifications might be appropriate to include in a PCCP.
- Modifications Acceptable for PCCP for a 510(k) or De Novo Device or PMA
- Changes in software consistent with the intended use to improve device performance.
- Certain changes in device design including dimensions, performance specifications, wireless communication, components or accessories, or the patient/user interface.
- Changes in software related to device compatibility and/or interoperability.
2. Modifications not appropriate for PCCP for a 510(k) or De Novo Device or PMA
- Change in device design that could affect the intended use of the device.
- Change to or removal of contraindications.
- Change to address a recall or safety issue.
- Change from prescription to over-the-counter use.
Predetermined Change Control Process Flow
- Potential change identified by the manufacturer
- Generate PCCP with the description of the required changes
- Submit PCCP to FDA
- FDA Review and Feedback
- If FDA approves it then
- the manufacturer can proceed with the implementation of changes
- if not the revise and resubmit the PCCP
A Predetermined Change Control Plan (PCCP) is essential for effectively managing changes in medical devices. By adopting a structured approach, organizations can ensure the safety, compliance, and quality of their products. This proactive strategy not only safeguards patient well-being but also enhances the organization’s credibility and reliability within the medical device market.