{"id":2728858,"date":"2023-06-12T03:06:47","date_gmt":"2023-06-12T07:06:47","guid":{"rendered":"https:\/\/wordpress-1016567-4521551.cloudwaysapps.com\/plato-data\/fda-draft-guidance-on-pccp-data-management-regdesk\/"},"modified":"2023-06-12T03:06:47","modified_gmt":"2023-06-12T07:06:47","slug":"fda-draft-guidance-on-pccp-data-management-regdesk","status":"publish","type":"station","link":"https:\/\/platodata.io\/plato-data\/fda-draft-guidance-on-pccp-data-management-regdesk\/","title":{"rendered":"FDA Draft Guidance on PCCP: Data Management | RegDesk"},"content":{"rendered":"
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The new article highlights the aspects related to data management and describes the way they should be addressed in a modification protocol.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Table of Contents<\/span><\/h2>\n<\/div><\/div>\n

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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Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to the regulatory requirements for a predetermined change control plan (PCCP) to be included in marketing submissions related to medical devices utilizing artificial intelligence\/machine learning (AI\/ML) technologies. Once finalized, the guidance will provide an overview of the existing regulatory framework and additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are they 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 underlying legislation and has been agreed with the authority in advance. <\/span><\/p>\n

The approach described in the guidance is intended to reduce the regulatory burden for medical device manufacturers with respect to modifications to existing products, the way they should be introduced, and the regulatory requirements associated thereto. Under the general rule, modifications included in a predetermined change control plan will not require a separate marketing submission, provided the plan was approved (authorized) by the FDA. <\/span><\/p>\n

The scope of the guidance covers, inter alia, the elements to be included in a Modification Protocol, which is a part of PCCP. In particular, the authority provides examples of elements of Modification Protocol components for machine learning device software functions (ML-DSFs).<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Content of a Modification Protocol<\/span><\/h2>\n

As it was mentioned before, a Modification Protocol should include the four main components addressing the following aspects:<\/span><\/p>\n

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  1. Data management practices;<\/span><\/i><\/li>\n
  2. Re-training practices;<\/span><\/i><\/li>\n
  3. Performance evaluation protocols; and<\/span><\/i><\/li>\n
  4. Update procedures. <\/span><\/i><\/li>\n<\/ol>\n

    The abovementioned aspects should be covered for each modification included in the Description of Modifications, which is another important section of a PCCP. At the same time, as it is stated by the authority, medical device manufacturers are also allowed to include additional components, should they reasonably deem it necessary. <\/span><\/p>\n

    With respect to the above, it is important to mention that the regulatory approach could be subject to changes based on the new information becoming available to the authority. The authority explicitly states that <\/span>the items below [in the guidance] are also not an exhaustive list of topics that a manufacturer is expected to cover, and all questions may not apply to all marketing submissions. <\/span><\/i>Furthermore, the authority is entitled to request additional components to be included in a Modification Protocol for specific medical device types. The level of detail the authority will expect will depend on the complexity of specific modifications and risks associated thereto. <\/span><\/p>\n

    The guidance further describes each of the main aspects outlined hereabove and highlights the key points to be taken into consideration by medical device manufacturers in this respect.<\/span><\/p>\n<\/div><\/div>\n

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    <\/span>Data Management<\/span><\/h2>\n

    In this section, the authority expects medical device manufacturers to provide detailed information on the way the data will be collected and used for training and testing. <\/span><\/p>\n

    For instance, with respect to data collection, the aspects of being addressed include, inter alia, the following:<\/span><\/p>\n