Contact the RQMIS Regulatory Consultant to develop initial strategies and conduct research to determine whether the future product version’s actual change (if it is significant) could be accommodated via PCCP.
What is a Predetermined Change Control Plan (PCCP)?
A PCCP is a preapproval plan proposed by a manufacturer in a regulatory submission that specifies:
- Certain planned modifications to a medical device,
- The protocol for implementing and controlling those modifications, and
- The assessment of impacts from the modifications.
Introduction:
The FDA has introduced this Predetermined Change Control Plan (PCCP), under section 515C(b)(2)(B) of the FD&C Act, a least burdensome option to support device modifications that have been specified as part of a device’s marketing authorization [e.g., PMA, De Novo, or a 510(k)]. Apart from the FDA, other regulatory agencies, such as Health Canada and MHRA, have started to accept the PCCP plan in regulatory submissions.
By including a PCCP in a device marketing submission, manufacturers can proactively specify and seek premarket clearance/approval for intended modifications to a device without needing to submit additional marketing submissions or obtain further FDA authorization before implementing such changes.
A new premarket notification is required if there is a modification in the intended use of a device or if there is a significant change or modification to a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design (software input, output, functions, etc.), material, chemical composition, energy source, or manufacturing process. This includes deviating from the preapproved PCCP
Information required for a PCCP:
There are three main components of a PCCP: 1) a Description of Modifications, 2) a Modification Protocol, and 3) an Impact Assessment. All three of these components are interrelated as follows: The Impact Assessment identifies the benefits and risks introduced by the specified, planned modifications and addresses how the verification and validation activities of the Modification Protocol will continue to assure the safety and effectiveness of the device.
Examples of a PCCP:
- Labeling changes to add sterile implant to the product list from non-sterile.
- Certain changes in software related to device compatibility and/or interoperability. For examples, changes to support device use on additional operating systems (android to iOS version, new data vendors and/or sources, or compatibility with additional devices)
- Changing a wired connection to a wireless connection of a device hardware system
All these changes should be executed with appropriate testing to assure that the modified device is safe and effective. For example, if you are adding a new wireless card to your device system, then appropriate electrical
Best practices to consider during PCCP preparation:
RQMIS can help you prepare and plan your next regulatory submission with the PCCP by incorporating the following basic principles/best practices:
- Early engagement with the FDA via Q-submission, regarding establishing the PCCP Plan.
- Use the verification and validation protocol already used for initial marketing submissions and the same acceptance criteria, if possible, from the test conducted in the original submission.
- Be specific and define what will be changed in future modifications.
- Including internal quality documentation about the modification plan and during the change is vital.
- Always remember that the PCCP can be applied only for the pre-approved/authorized modifications by the FDA.
- PCCP is different from a letter to file/Note to file. You can always make minor modifications to a 510(k) cleared device within the FDA’s requirements.
- Once the PCCP is implemented, RQMIS and the client must update the internal Quality System Regulation (QSR) and FDA, as applicable (e.g., for a PMA device, this PCCP implementation should be reported in the annual periodic reports).
- Most importantly, the PCCP is an option to implement, not an obligation to implement.
- If we encounter new risks or challenges while implementing the change, RQMIS and the client must engage with the FDA.
In a nutshell, if you have a PCCP approved by the FDA in a PMA, De Novo, or 510(k) submission, you do not need to submit a PMA supplement or special or traditional 510(k) for the agreed-upon changes. By minimizing future regulatory submissions, you can channel your focus on performing required verification and validation testing to implement the predetermined change control plan. In the long run, you can strategically roll out changes more efficiently and quickly with this approach.