{"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":"
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 \n\t\t\t<\/div>\n <\/p>\n \t\t\t\t <\/p><\/div>\n <\/p>\n <\/p>\n 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 \n\t\t\t<\/div>\n <\/p><\/div>\n <\/p>\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> 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> 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> <\/p>\n \t\t\t\t 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> <\/p>\n In summary, according to the guidance, a new 510(k) is not mandatory when adding a protocol to a new device model, provided the protocol has been cleared in another model by the same manufacturer, and both models share technological characteristics. In addition to this, the document outlines the key criteria to be taken into consideration when determining whether the modifications introduced necessitate a new 510(k).<\/span><\/p>\n<\/div><\/div>\n <\/p>\n https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/submission-premarket-notifications-magnetic-resonance-diagnostic-devices<\/a><\/p>\n<\/div><\/div>\n \n\t\t\t<\/div>\n <\/p><\/div>\n <\/p>\n RegDesk<\/strong> is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.<\/p>\n<\/div><\/div>\n \n\t\t\t<\/div>\n <\/p><\/div>\n <\/p><\/div>\n \t\t<\/div>\n \n\t<\/div>\n <\/p><\/div>\n <\/p>\n –><\/p>\n 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. Table of content The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of […]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":344388,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[52],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/344383"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=344383"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/344383\/revisions"}],"predecessor-version":[{"id":344387,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/344383\/revisions\/344387"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/344388"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=344383"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=344383"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=344383"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}<\/span>\n\t\t\t<\/div>\n<\/p><\/div>\n
<\/span>Table of content<\/span><\/h2>\n<\/div><\/div>\n
<\/span>Clinical Image Submission<\/b><\/span><\/h2>\n
<\/span>
<\/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>
<\/span>
<\/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
<\/span>
<\/span>Every image should be accompanied by details about the target anatomical site, scan parameters used, and total imaging time.<\/span><\/p>\n
<\/span>
<\/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<\/span>\n\t\t\t<\/div>\n
<\/span>Device Modifications and 510(k) Submissions<\/b><\/span><\/h2>\n
<\/span>
<\/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\n
<\/span>Such modifications need testing for signal-to-noise ratio (SNR), geometric distortion, and image uniformity. A measurement of the magnetic field\u2019s homogeneity and stability over extended periods is also required.<\/span><\/li>\n
<\/span>Such alterations require assessments of geometric distortion, slice profile thickness, and the system\u2019s acoustic output. PNS control changes should also be documented.<\/span><\/li>\n
<\/span>Thus, testing for RF energy deposition, coil surface heating, SNR, and image uniformity is necessary. However, changes in the material type or composition for non-patient contacting coil housing typically don\u2019t need a new 510(k) submission.<\/span><\/li>\n
<\/span>Such changes should be tested for SNR, image uniformity, coil surface heating, and biocompatibility.<\/span><\/li>\n
<\/span>For instance, introducing a metal artifact reduction pulse sequence would necessitate a new 510(k) submission, complete with performance data.<\/span><\/li>\n
<\/span>Factors to consider include changes to the target anatomical area, contrast characteristics, and coil restrictions. However, merely re-ordering existing pulse sequences within a protocol wouldn\u2019t necessitate a new 510(k).<\/li>\n<\/ul>\n<\/div><\/div>\n<\/span>Conclusion<\/b><\/span><\/h2>\n
<\/span>Source<\/span><\/h2>\n
<\/span>How Can RegDesk Help?<\/span><\/h2>\n
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