By Laurie Reed
On Aug 22, 2024, the US FDA ‘s CDRH and CBER divisions jointly issued a draft guidance document titled, “Predetermined Change Control Plans for Medical Devices.”
Why was this Draft Guidance Released?
In 2022 as part of a reform act, FDA added “Predetermined Change Control Plans (PCCPs) for Devices to the Federal Food, Drug, and Cosmetic Act” which had provisions for devices requiring PMAs or 510(k)s. This new guidance document issued in 2024 includes recommendations on the specific information to include in a PCCP within a marketing submission. FDA reviews the PCCPs as part of the submissions “to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP.”
So basically, manufacturers can pre-plan modifications that they will make to their device in the future, and as long as it is described upfront and approved by FDA as part of a PCCP in their market submission, they would not need to seek a PMA supplement or new 510(k) for the changes. Of course, they would need to make sure the execution of such modifications remains consistent with the content described in their cleared PCCP.
There are several other specific guidance documents issued by FDA where PCCPs are introduced and mentioned, but they are specific to certain device categories or types. This new, broader guidance document is intended to be more general and cover all device types.
FDA’s Guiding Principles for PCCPs
Since the PCCP process is fairly new, FDA included some helpful guiding philosophies to better educate manufacturers about their current thinking on this pathway. Here are the Guiding Principles discussed in the draft guidance:
Information included in the PCCP should enable FDA to assess the reasonable assurance of safety and effectives and substantial equivalence of the device.
PCCPs may be the least burdensome pathway to support device modifications, but they are optional, and FDA will follow a risk-based approach to determine if a PCCP is the best framework.
PCCPs are part of a device’s marketing authorization so manufacturers are bound to implement the device updates in accordance with the cleared PCCP.
PCCPs should be extremely specific about what updates will be made to the device over time, not a list of any/all modifications the manufacturer might possibly make. Keeping the PCCP specific facilitates FDA review.
PCCPs harmonize with existing FDA Device Modifications guidances; the documents are intended to work together so that a manufacturer can use the collective guidances to determine if a modification would require a new marketing submission, and if so, whether a PCCP is feasible.
How Does the PCCP Process Work?
Following the approved PCCP is critical to ensure the safety and effectiveness of the modified device. Deviating from the PCCP is not recommended (or supported by law) and could trigger the requirement for a new marketing submission. However, it is important to note that device modifications that would not qualify as needing a new marketing submission are not considered deviations from an authorized PCCP.
PCCPs must be established through the PMA, 510(k), or De Novo pathway and receive clearance from FDA along with the general marketing submission. Once a PCCP is approved, the manufacturer can implement the planned changes but should do so within the existing risk management framework and under their Quality Management System (QMS). Prior to implementing a planned modification from the PCCP, the manufacturer should make an assessment as to whether the change can be implemented in accordance with the approved plan. If not, it may be necessary to seek a new marketing submission.
FDA doesn’t plan to re-review every implementation made as part of an approved PCCP. The expectation seems to be that manufacturers will simply implement the changes as described in the approved PCCP and document them in their QMS. For PMAs, FDA expects the manufacturer to include a section in their Annual Report that describes any changes that were implemented over that year as part of an approved PCCP. For 510(k)s, re-review would likely only occur once a new marketing submission was triggered by changes outside the PCCP. However, “once a 510(k) for a device that includes modifications that have been implemented consistent with the authorized PCCP has been cleared in a subsequent marketing submission, such device can now serve as an eligible predicate device.”
What Content Should PCCPs Include?
The draft guidance suggests the PCCP should include, at a minimum, three parts as described below:
A detailed Description of Modifications – outlines the specific, planned modifications to be made to the device
A Modification Protocol – describes the verification and validation activities with pre-defined acceptance criteria
An Impact Assessment – ties #1 and #2 above together, summarizing the benefits and risks associated with the new device modifications and how they will be validated
The draft guidance contains more detailed descriptions of the expected content to include in each of these sections with some good examples. They generally recommend that PCCPs be kept specific, limited to only a small number of changes, and contain items that can be easily verified and validated.
Implications for Labeling
In most cases, FDA recommends that the device labeling include a statement that the device has an authorized PCCP. It is also recommended that the device labeling be assessed and updated as changes described within the PCCP are implemented, to ensure users are instructed about the new changes and features and how this might affect their use of the device.
What Kinds of Changes can a PCCP Cover?
It is recommended that the types of modifications a manufacturer include in the PCCP are ones that are intended to maintain or improve the safety and effectiveness of the device over time. The manufacturer should make an assessment as to whether a device modification is appropriate for inclusion in a PCCP using this decision tree recreated from the draft guidance:
Most importantly, changes that are implemented under a PCCP cannot alter the intended use of the device and must allow the device to remain substantially equivalent to its predicate. Any modifications that could introduce new risks and/or new hazardous situations are NOT recommendation for inclusion in a PCCP.
The table below provides examples of appropriate or inappropriate device modifications:
Appropriate Device Modifications | Inappropriate Device Modifications |
Changing a device's dimensions | Changing the device control mechanism or operating principles |
Updating a device's sterilization, packaging, or transport methods | Modifying the device design so that it results in an altered intended use of the product (such as going from single use to re-usable, or prescription to over-the-counter) |
Modifying the device components by selecting new raw materials | Updating or removing contraindications |
Updating the labeling to specify use of the device with an additional device or component | Anything that would require new clinical data to be generate |
Making software changes to improve device compatibility or interoperability |
Can Manufacturers Modify a PCCP?
Yes, manufacturers can modify a previously authorized PCCP, but it will need to be re-reviewed by FDA according to the chosen regulatory pathway. For example, a PMA Supplement pathway would be a reasonable time to ask for re-review of a modified PCCP. Manufacturers should be prepared to communicate the specific differences in the original plan vs. the new one (FDA suggests using Tracked Changes).
Final Thoughts
It’s exciting to see FDA creating new pathways that will help speed up medical device manufacturer’s submission timelines by enabling quicker updates to commercially available products. Since the PCCP process is in its infancy, the Agency highly recommends early engagement regarding a proposed PCCP, especially for specific devices such as combination products and devices that are high-risk, life-supporting and/or implantable. Manufacturers are encouraged to make use of the Q-Submission program so the two parties can discuss and agree on the scope of the PCCP. Since this is a fairly new option, FDA anticipates that these discussions will be interactive.
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