Introduction
The FDA's draft guidance on Predetermined Change Control Plans (PCCPs) for medical devices was developed following the enactment of Section 515C of the FD&C Act in December 2022 as part of the Food and Drug Omnibus Reform Act (FDORA). PCCPs are documents that outline planned modifications to a device, detailing how these changes will be developed, validated, and assessed to ensure continued safety and effectiveness. By incorporating PCCPs into marketing submissions, manufacturers can implement approved modifications without requiring additional submissions for each change. The guidance provides recommendations for the content of PCCPs, including descriptions of planned modifications, protocols for validation and implementation, and impact assessments to mitigate risks. This approach streamlines regulatory processes while maintaining high safety standards for devices requiring premarket approval (PMA) or premarket notification (510(k)).
2. Scope
The FDA currently considers the following categories of device modifications suitable for inclusion in a PCCP as defined in this guidance.
A PCCP allows manufacturers to propose specific device modifications in advance, which frequently require a new marketing submission (e.g., a PMA, 510(k), or De Novo).
The manufacturer may execute the pre-approved modifications without requiring additional approvals, provided that they are executed precisely as outlined in the permitted PCCP, following FDA authorization of a PCCP during a device's marketing submission.
This recommendation is exclusively applicable to revisions that typically require a new submission due to potential safety or efficacy implications.
It does not include irrelevant modifications that are addressed in the standard Quality System documentation. It primarily concerns the device component of device-led combination products, with the exception of the pharmacological or biologic components.
It is recommended that manufacturers promptly engage with the FDA through initiatives such as the Q-Submission Program to ensure that their proposed PCCP encompasses the necessary scope and data.
The PCCP should not attempt to replace the existing regulatory requirements that are essential, but rather to expedite the process of making substantive, foreseeable modifications.
3. Guiding Principles for PCCPs
A PCCP is similar to a pre-approved "to-do list" for future modifications that a corporation intends to implement to a medical device. A PCCP enables companies to anticipate minor modifications and obtain FDA approval during the initial marketing application, rather than requesting permission for each one. This can save a significant amount of time and effort, provided that the FDA approves the plan to ensure the device's safety and effectiveness.
In order to approve a PCCP, the FDA evaluates all of the information and determines whether the device will continue to satisfy the necessary safety, effectiveness, or equivalence standards with its future modifications. This review is conducted in accordance with the same approval or clearance standards that are applied to all devices, and it is based on a risk-based approach. This approach involves the FDA evaluating the device's complexity, risk, and history.
Although PCCPs are entirely optional, they may serve as the least burdensome option. When implemented effectively, they mitigate the necessity for new marketing submissions each time a modification is implemented, thereby enhancing the efficiency of both the company and the FDA. Upon authorization, a PCCP is incorporated into the official marketing sanction of the device. In the event that the organization elects to implement those modifications, it is imperative that they adhere to the PCCP in its entirety, as it was approved.
Additionally, it is crucial that a PCCP is both specific and restricted. It should not consist of an extensive inventory of potential modifications. The FDA favors a limited number of modifications that are plainly identified and can be tested, and that do not alter the device's purpose or create it entirely different. The FDA may not approve the PCCP if it is too broad or contains unrelated modifications, as it would be unable to ensure the continued safety or performance of the product.
In summary, PCCPs enable manufacturers to expedite and optimize the process of implementing critical device updates, provided that they are carefully planned, FDA-approved, and effective within the device's intended use.
4. Policy for PCCPs
This section defines the regulations and expectations that govern the use of a PCCP by companies to implement updates or modifications to a medical device without the necessity of submitting a new marketing submission each time—provided that the modifications are pre-approved through a PCCP.
a. What defines the Validity of a PCCP?
A genuine PCCP must be authorized as part of the initial marketing submission (510(k), PMA, or De Novo).
The company is permitted to implement the intended modifications without the need to resubmit them, provided that they adhere to the specifications mentioned in the PCCP.
b. Elements of a PCCP
A comprehensive PCCP comprises the following:
Modification Description: The precise modifications that will be implemented.
Modification Protocol - The process by which these modifications will be developed, tested, and validated.
Impact Assessment - The manner in which these modifications may influence the device's safety or functionality, as well as the methods by which risks will be mitigated.
c. What happens if you deviate from the PCCP?
A new marketing submission may be necessary if the modifications do not adhere to the protocol or exceed the authorized PCCP.
The product may be labeled adulterated or misbranded as a result of unauthorized modifications, which could result in legal repercussions.
d. The Process of Submitting a PCCP and may be submitted with:
Original PMA or 510(k)
Supplements such as 180-day, 135-day, or real-time
De Novo Requests
PCCPs must be properly designated in the submission with a title, version control, and inclusion in summaries and labeling (if applicable).
e. Using the PCCP After approval
Manufacturers are required to implement the approved protocol for updates.
The labeling should be updated to reflect the modifications implemented under the PCCP to guarantee that users are aware of the changes and are able to safely operate the device.
f. Modifying an Existing PCCP
A new submission (De Novo, 510(k), or PMA supplement) is typically necessary for a corporation to modify its already approved PCCP.
The FDA recommends that the new PCCP be submitted in a tracked changes version for comparison with the original.
g. FDA Review and Interactions
The FDA will evaluate the PCCP in the same manner as other device features, with an emphasis on the management of modifications.
The Q-Submission Program enables companies to engage in advanced discussions regarding modifications.
FDA may request clarifications or modifications during the assessment process prior to approval.
5. Types of Modifications
A manufacturer can utilize a PCCP to pre-authorize and plan specific modifications to a medical device without the need for a new marketing submission each time. However, only specific categories of modifications are eligible for this. This section defines the types of device modifications that may be incorporated into a PCCP based on the regulation of the device, which is dependent on:
I. 510(k) or De Novo pathway
II. PMA (Premarket Approval) pathway
There are two primary regulatory categories for PCCP modifications:
A. Modifications that may be included for 510(k) or De Novo Submissions:
Modifications to software, such as version updates
Modifications to the device's design (minor modifications that do not alter the fundamental functionality)
Limited modifications to manufacturing processes or equipment
Modifications to the labeling that do not alter the intended purpose
Restricted:
Significant modifications to the intended purpose
Modifications that would influence the classification of devices
It is important to note that the device must continue to be substantially equivalent to its predicate following the modification.
B. Modifications that may be included for PMA devices (high-risk devices):
Modifications to the design to enhance performance
Software upgrades
Modifications to manufacturing processes or facilities
Component modifications are permissible provided that safety and efficacy are maintained.
For example, altering the material or software logic of a sensor that has been validated and satisfies the acceptance criteria.
Restricted:
Completely new designs
New intended purpose
Anything demanding new clinical evidence
Important Considerations: The modification must adhere to the device's original intended purpose. No new concerns regarding safety or efficacy must be presented.
Each modification to the PCCP must include the following:
A concise explanation
A protocol for modification
A risk-impact assessment
6. Recommended Content for PCCP
a. Modifications Description
The manufacturer should explicitly specify the modifications to their device that they intend to implement in the future in this section of the PCCP. Modifications to design, software, manufacturing processes, labeling, or other critical components may be included. The description must contain an adequate amount of technical detail to enable the FDA to comprehend the precise nature of the proposal. Furthermore, it should specify the justification for each modification and the manner in which they are consistent with the device's intended use. It is crucial that the modifications are not abstract concepts, but rather specific, well-defined adjustments. The objective is to ensure that each modification is measurable, justifiable, and appropriately constrained by supplying clarity and specificity.
b. Protocol for Modification
The modification protocol delineates the process of developing, implementing, and validating the proposed modifications. The manufacturer should specify the specific procedures and methods that will be employed to guarantee the safe and effective execution of the modifications. This encompasses predetermined acceptance criteria, validation activities, and planned testing strategies. The protocol must prove that the manufacturer has implemented a risk-based and robust approach to change management that does not compromise the device's safety or performance. It should also specify the process by which labeling will be revised in the event that a modification affects instructions or warnings. In essence, this protocol serves as the blueprint for the compliant and systematic implementation of the modifications previously described.
c. Assessment of Impact
In order to assess the potential hazards and benefits of each proposed modification, an impact assessment is required. It should address the potential impact of each modification on the device's safety, effectiveness, and user experience. The assessment must prove that the validation activities outlined in the modification protocol have effectively identified, mitigated, and controlled risks. This section guarantees that the proposed modifications do not introduce new hazards or diminish the device's overall benefit-risk profile. It also serves to emphasize that the modifications are in accordance with regulatory mandates and will not require a new marketing submission as long as they remain within the authorized PCCP.
d. Traceability Between Sections
Traceability is a critical feature that guarantees transparency throughout the PCCP document. The testing strategies in the protocol and the outcomes considered in the impact assessment must be explicitly linked to each change described in the first section. This connection allows the FDA to effortlessly confirm that each proposed modification has a corresponding risk evaluation and validation method. This mapping is frequently facilitated by the organization of the PCCP, which may involve the use of visual aides, tables, or references. The PCCP is more effective as a pre-approved change management tool and is simpler to review when traceability is ensured.
7. Examples of Modifications for PCCPs
The following section offers practical examples of the categories of device modifications that may be appropriate for inclusion in a Predetermined Change Control Plan (PCCP). The objective is to assist manufacturers in comprehending the types of future updates or modifications that can be pre-authorized by the FDA without the necessity of a distinct submission for each.
1. Software Updates (Including AI/ML)
For instance, an organization intends to enhance an AI algorithm that is implemented in diagnostic software in the future.
The updates are predetermined and adhere to a predetermined testing and validation protocol, which is why they are compatible with PCCP.
Key Point: By preventing multiple submissions, PCCPs can facilitate the safe and continuous enhancement of software, particularly AI models.
2. Replacement of Hardware Components
For instance, replacing a sensor with an updated version that maintains the same interface and functionality.
The modification does not necessitate a new FDA submission if the new sensor undergoes pre-approved testing methods.
Key Point: PCCPs are advantageous when suppliers discontinue components, enabling manufacturers to maintain compliance with minimal disruption.
3. Significant Changes
For instance, the substitution of a different plastic in a device handle as a result of the supplier's discontinuation.
The reason it is compatible with PCCP is that no additional submission is required if the materials are evaluated for safety and performance in the PCCP plan in advance.
Key Point: If risk assessments are conducted, minor physical modifications that do not affect device functionality may be incorporated into PCCPs.
4. Updates to the Sterilization Process
For instance, Transitioning from ethylene oxide (EtO) sterilization to gamma irradiation.
The procedure has been pre-approved and validated to guarantee that it will not affect the safety or functionality of the device, which is why it is compatible with PCCP.
Key Point: When pre-tested and validated, PCCPs can simplify the process of modifying sterilization methods.
5. Modifications to Labeling
For instance, revising the usage instructions to incorporate a new accessory that is compatible.
Why it is appropriate for PCCP: These are low-risk and frequently result from minor product evolution, which can be anticipated in advance.
Key Point: If the PCCP is adequately defined, a comprehensive review of all labeling modifications is unnecessary.
9. Sample of 510(k) Summary Information Regarding the PCCP
This section offers a sample of how to summarize a PCCP (Predetermined Change Control Plan) in a 510(k) submission for a medical device. It concentrates on a device that has undergone specific software modifications, including the addition of a new wireless card and the upgrading of the operating system, as part of its PCCP.
The summary highlights:
What changes are planned? (e.g., new hardware or software updates)
How will these changes be tested? (e.g., using FDA-recognized standards for safety and performance)
How will changes be validated? (e.g., performance testing to ensure the device remains as safe and effective as before)
How will users be informed? (e.g., updates in labeling or instructions for use)
The FDA suggests that these details be presented in a table format, which should include the following:
The planned modifications
Related test and validation methods
Communication plans to users
Throughout the device's lifecycle, this framework guarantees compliance, safety, and transparency.
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