The new article highlights the aspects related to the way changes to a change control plan could be introduced, and also provides additional explanations regarding the way the proposed modifications should be described in the respective section of a plan.
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The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance describing the approach to be applied with respect to a Predetermined Change Control Plan (PCCP) related to medical devices utilising artificial intelligence/machine learning (AI/ML) technologies. In particular, the document provides additional clarifications regarding the existing regulatory requirements associated with marketing submissions, as well as recommendations to be followed by medical device manufacturers (software developers) in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing regulatory framework and has been agreed with the authority in advance.
In particular, the scope of the guidance addresses the change-related aspects reflecting the specific nature of the ML-enabled Device Software Functions (ML-DSFs).
Under the general rule, submission of a PCCP in the course of the initial application for marketing approval is expected to reduce the regulatory burden associated with implementing further changes to the product after placing it on the market – certain changes to it would not require a new marketing application, as long as such changes are duly reflected in a PCCP initially submitted by the manufacturer.
Modifying a PCCP
In certain cases, medical device manufacturers may decide to introduce changes to a PCCP for a medical device already allowed for marketing and use in the country. In this respect, the approach to be applied by the authority will be the following: because the modifications described in the PCCP include device changes that would otherwise require a PMA supplement, De Novo submission, or new 510(k) premarket notification, at this time, FDA believers that modifications to an authorized PCCP will generally constitute changes to the ML-DSF that require a new marketing submission for the device, which will include the modified PCCP, i.e., FDA expects that the modified PCCP will need to be reviewed and established as part of the premarket review of the modified device because a modification to the PCCP will generally significantly affect the safety or effectiveness of the device. Should it appear that the suggested changes to the said plan are the only significant modification to the initial authorization, the authority will focus its review efforts on such changes.
Thus, a medical device manufacturer interested in making changes to a PCCP would have to submit a new application for marketing approval in accordance with the respective regulatory requirements for the specific type of device with a new PCCP included.
Modification Description
As mentioned before, a PCCP is expected to provide detailed information about the modifications to be introduced to the product in the future after it becomes available on the market. The authority additionally emphasizes the importance of including the description of each planned modification and paying attention to how the changes will impact the characteristics and performance of the device. It is also stated that the number of changes included in a PCCP should be limited to facilitate the review. At the same time, all of them should be specific, representing the ones that could be verified and validated.
Description Goals
According to the guidance, a Description of Modifications section in the said plan should provide detailed enough information about the modifications to an ML-based medical device the manufacturer intends to implement in the future. In particular, it is stated that the Description of Modifications draws a “range of FDA-authorized specifications” around the initial characteristics and performance of the device that, following the agreed upon verification and validation described in the Modification Protocol, can be implemented without a new marketing submission. It is also important to mention that the authority may also determine that a Modification Protocol supports some but not all modifications identified in a PCCP; in such cases, only those modifications that are appropriate in the FDA’s findings of substantial equivalence or reasonable assurance of safety and effectiveness would be included in the authorized PCCP.
Description of Modifications: Content
The document further provides additional recommendations regarding the content of the Description of Modifications section of a PCCP. According to the document, this section should include the details of the individuals proposed the modifications suggested, and also the appropriate rationale for all the changes. In certain cases, this section could describe multiple changes, so it is recommended to provide references to the respective changes to labeling used for the device in question.
As it was mentioned before, the authority encourages medical device manufacturers to ensure the modifications described in a PCCP are specific and also could be verified and validated. The level of detail in the description provided should be sufficient for the authority to understand their nature and assess the potential impact they may have on the safety and performance of a medical device. Each of them should also be linked to the appropriate performance evaluation activity as described in the Modification Protocol.
As explained by the authority, the Description of Modifications should clearly state if the planned modifications are proposed to be implemented automatically (i.e., whether the modifications are implemented automatically by software) or whether modifications are implemented manually (i.e., involving steps that require human input, action, review, and/or decision-making, and therefore are not implemented automatically).
In summary, the present FDA guidance describes the approach to be applied by the parties responsible for medical devices, should they decide to make changes to the PCCP for a product already placed on the market. The document also outlines the scope of information to be included in the Description of Modifications section of the said plan.
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