{"id":344383,"date":"2023-11-16T04:41:24","date_gmt":"2023-11-16T09:41:24","guid":{"rendered":"https:\/\/platohealth.ai\/fda-guidance-on-premarket-notifications-for-mrdd-clinical-images-and-device-modifications-regdesk\/"},"modified":"2023-11-20T16:07:57","modified_gmt":"2023-11-20T21:07:57","slug":"fda-guidance-on-premarket-notifications-for-mrdd-clinical-images-and-device-modifications-regdesk","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/fda-guidance-on-premarket-notifications-for-mrdd-clinical-images-and-device-modifications-regdesk\/","title":{"rendered":"FDA Guidance on Premarket Notifications for MRDD: Clinical Images and Device Modifications | RegDesk","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
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The article highlights the aspects related to clinical images to be submitted by the applicant and also describes the approach to be applied concerning modifications to medical devices covered by the scope of the guidance.<\/span><\/p>\n<\/div><\/div>\n

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

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The <\/span>Food and Drug Administration <\/span><\/a>(FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the submission of premarket notifications for magnetic resonance diagnostic devices (MRDDs).<\/span><\/p>\n

The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance with it.<\/span><\/p>\n

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.<\/span><\/p>\n

Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the respective legislation. It has been agreed with the authority in advance. <\/span><\/p>\n<\/div><\/div>\n

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<\/span>Clinical Image Submission<\/b><\/span><\/h2>\n

First of all, the authority states that when introducing a new system, it is mandatory to provide the FDA with clinical images that demonstrate the diagnostic capabilities of the system in question.<\/span>
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<\/span>These images validate the performance of various pulse sequences. If a single pulse sequence finds application across multiple clinical protocols, its sample images should delineate its ability to produce the desired contrast in every protocol. <\/span>
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<\/span>As explained by the authority, a scientific rationale accompanied by sample images should suffice for a pulse sequence used across several protocols.<\/span><\/p>\n

The FDA requires that these images be in electronic DICOM format. Furthermore, the authority additionally emphasizes the importance of erasing any patient-specific data before submission. <\/span>
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<\/span>Every image should be accompanied by details about the target anatomical site, scan parameters used, and total imaging time.<\/span><\/p>\n

However, it is important to mention that there is an alternative to submitting the entire image set \u2013 instead, the applicant can submit a statement from a US-certified radiologist affirming the diagnostic quality of the images. <\/span>
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<\/span>This statement should describe the sequences and anatomical areas the radiologist examined. If there were any issues with image quality or evaluation, these should be thoroughly addressed. Alongside the statement, a small set of representative clinical images should be provided.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Device Modifications and 510(k) Submissions<\/b><\/span><\/h2>\n

The scope of the guidance also covers the aspects related to modifications to MRDDs. According to <\/span>21 CFR 807.81(a)(3)<\/b>, any modification to a device that could potentially impact its safety or its intended use necessitates a new 510(k) submission. <\/span>
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<\/span>The FDA has provided a non-exhaustive list of modifications that would typically require this. According to the document, the include the changes to:<\/span><\/p>\n