The new article addresses the aspects related to the connection between different sections of a predetermined change control plan, as well as to the impact assessment medical device manufacturers should perform in order to ensure the modifications will not affect the safety and effectiveness of a medical device.

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance dedicated to a Predetermined Change Control Plan (PCCP) to be included in marketing submissions related to medical devices utilizing Artificial Intelligence (AI) and Machine Learning (ML) technologies. Once finalized, the guidance will provide additional recommendations medical device manufacturers (software developers) should consider when preparing marketing submissions in order to ensure compliance with the applicable regulatory requirements, as well as a general overview of the existing regulatory framework and clarifications regarding specific aspects thereof. At the same time, it is important to mention that provisions of the guidance and recommendations provided therein are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states an alternative approach could be applied, provided such an approach is in line with the underlying legislation and has been agreed with the authority in advance. 

The approach described in the document is intended to reduce the regulatory burden for the parties interested in placing AI/ML-based medical devices on the US market. In particular, it provides that the changes described in the aforementioned plan will not require a separate marketing submission before being implemented as long as the respective plan has been reviewed and authorized by the FDA. The document also describes the way additional changes could be introduced to a PCCP after it has been approved by the authority, should such changes be reasonably necessary to ensure it properly describes the medical device in question and specific aspects associated thereto. 

The scope of the guidance covers, inter alia, the aspects related to traceability between the Description of Modifications section and the Modification Protocol section – the main sections of a PCCP to be included in marketing submissions for AI/ML-powered products.

Traceability: Key Points

First of all, the authority emphasizes the importance of ensuring clarity on which parts of the Modification Protocol are applicable to each modification within the Description of Modifications. Should a plan contain information about multiple modifications, it could be convenient to structure this information as a table – present FDA guidance provides an example of such a table to illustrate how the approach described could be followed. According to this example, for each of the modifications covered by a plan, the authority expects the manufacturer to provide the details on:

  • Data management practices;
  • Re-training practices;
  • Performance evaluation; and
  • Update procedures.

Impact Assessment

Another important aspect addressed in the guidance is an impact assessment which, for the purpose of the present guidance, stands for the documentation of the assessment of the benefits and risks of implementing a PCCL for an ML-DSF [“machine learning device software function”], as well as the mitigations of those risks. The authority also mentions that the manufacturer’s existing quality system should be used as the framework in which to conduct an Impact Assessment for the modifications set forth in the PCCP. 

As further explained by the FDA, the scope of documentation related to the matter the authority expects an applicant to submit as part of a marketing submission should contain:

  • A composition between versions and modifications of a medical device in question;
  • Details about the risks and benefits of each modification;
  • Clarification on the way the approach described in the Modification Protocol will be followed to ensure continued safety and proper performance of a medical device;
  • Explanation of the impact implementation of one of the changes will have over the others; and 
  • Description of the collective impact of implementing all modifications.

According to the guidance, the authority believes it is important to address these elements in an Impact Assessment in order to demonstrate that the combination of the proposed modifications is unlikely to introduce additional, unmitigated risks and that the safety and effectiveness of the device under review is maintained as modifications are implemented. The authority also expects the manufacturer to include the overall assessment of the impact modifications suggested will have on the functionality of the device in general, all of its functions and hardware. In this respect, the authority also refers to a guidance document dedicated to multiple-function device products in terms of information to be included in a marketing submission in order for the authority to be able to assess the aspects associated thereto. 

It is also stated that in certain cases (for certain products), the least burdensome approach will be to include the content of the Impact Assessment within the Modification Protocol rather than as a separate section within the PCCP. 

In summary, the present FDA guidance describes in detail the approach to be applied when describing how different sections of a predetermined change control plan should correspond to each other. The document also highlights the aspects related to an impact assessment to be carried out by a party responsible for a medical device in order to assess the risk and benefits associated with the modifications suggested, as well as the impact such modifications will have on the overall functionality and performance of the device in question, its safety and effectiveness when used for the initial intended purpose.

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