{"id":7910,"date":"2024-12-18T19:08:58","date_gmt":"2024-12-18T11:08:58","guid":{"rendered":"https:\/\/regask.com\/?p=7910"},"modified":"2024-12-18T19:08:58","modified_gmt":"2024-12-18T11:08:58","slug":"directives-de-la-fda-sur-les-dispositifs-dia-pccp","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/fda-ai-device-guidance-pccp\/","title":{"rendered":"La FDA (\u00c9tats-Unis) publie des directives d\u00e9finitives sur les changements pr\u00e9d\u00e9termin\u00e9s\u2026"},"content":{"rendered":"<p>Le 4 d\u00e9cembre 2024, la Food and Drug Administration (FDA) des \u00c9tats-Unis a publi\u00e9 ses directives finales, <strong>\u00ab Recommandations de soumission marketing pour un plan de contr\u00f4le des modifications pr\u00e9d\u00e9termin\u00e9 pour les fonctions logicielles des appareils dot\u00e9s d&#039;intelligence artificielle. \u00bb<\/strong> Cette mise \u00e0 jour repr\u00e9sente une avanc\u00e9e cl\u00e9 dans le <a href=\"https:\/\/regask.com\/fr\/directives-de-la-fda-sur-les-dispositifs-medicaux-lies-au-covid-19\/\">Cadre r\u00e9glementaire de la FDA<\/a>, con\u00e7u pour soutenir l&#039;innovation continue dans les dispositifs m\u00e9dicaux bas\u00e9s sur l&#039;IA tout en pr\u00e9servant leur s\u00e9curit\u00e9 et leur efficacit\u00e9.<\/p>\n<p>Le guide introduit le concept de <strong>Plan de contr\u00f4le des changements pr\u00e9d\u00e9termin\u00e9 (PCCP)<\/strong>, qui d\u00e9taille les modifications pr\u00e9vues aux dispositifs dot\u00e9s d&#039;IA. Le PCCP comprend les m\u00e9thodologies de d\u00e9veloppement, de validation et de mise en \u0153uvre de ces changements, ainsi que l&#039;\u00e9valuation de leur impact sur la s\u00e9curit\u00e9 et l&#039;efficacit\u00e9 du dispositif.<\/p>\n<p><strong>Points saillants :<\/strong><\/p>\n<ul>\n<li><strong>Champ d&#039;application :<\/strong><br \/>\nCes directives s&#039;appliquent aux dispositifs dot\u00e9s d&#039;IA de diverses cat\u00e9gories de produits, notamment ceux examin\u00e9s dans le cadre de la notification pr\u00e9alable \u00e0 la mise sur le march\u00e9 510(k), de la demande de classification de novo et de l&#039;autorisation pr\u00e9alable \u00e0 la mise sur le march\u00e9 (PMA). Elles englobent \u00e9galement les composants des produits combin\u00e9s pilot\u00e9s par des dispositifs.<\/li>\n<li><strong>Processus d&#039;examen :<\/strong><br \/>\nLa FDA \u00e9valuera le PCCP dans le cadre de la demande de mise sur le march\u00e9 du dispositif, garantissant ainsi que les modifications pr\u00e9vues sont conformes aux normes de s\u00e9curit\u00e9 et d&#039;efficacit\u00e9. Cela \u00e9limine la n\u00e9cessit\u00e9 de soumettre une nouvelle demande de mise sur le march\u00e9 pour chaque modification mentionn\u00e9e dans le PCCP.<\/li>\n<li><strong>Commentaires et mises \u00e0 jour du public :<\/strong><br \/>\nLes r\u00e9visions apport\u00e9es aux lignes directrices tiennent compte des commentaires du public, notamment des clarifications sur le champ d&#039;application, les exigences d&#039;\u00e9tiquetage, les processus de mise en \u0153uvre dans le cadre d&#039;un PCCP autoris\u00e9 et les recommandations en mati\u00e8re de surveillance post-commercialisation. Les d\u00e9finitions d&#039;\u00ab\u00a0intelligence artificielle\u00a0\u00bb et d&#039;\u00ab\u00a0apprentissage automatique\u00a0\u00bb ont \u00e9t\u00e9 mises \u00e0 jour pour s&#039;aligner sur celles-ci. <strong>D\u00e9cret ex\u00e9cutif 14110<\/strong> publi\u00e9 le 30 octobre 2023.<\/li>\n<\/ul>\n<p>Ces orientations marquent une \u00e9tape importante dans les pratiques r\u00e9glementaires relatives aux appareils dot\u00e9s d\u2019IA, en \u00e9quilibrant l\u2019innovation avec les priorit\u00e9s de sant\u00e9 publique.<\/p>\n<p>Pour plus d\u2019informations ou pour discuter de strat\u00e9gies de conformit\u00e9, veuillez nous contacter.<\/p>","protected":false},"excerpt":{"rendered":"<p>On December 4, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance, &#8220;Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.&#8221; This update represents a key advancement in the FDA&#8217;s regulatory framework, designed to support continuous innovation in AI-enabled medical devices while maintaining their safety and&#8230;<\/p>","protected":false},"author":43,"featured_media":7925,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,39],"tags":[165,593,609,610,611],"class_list":["post-7910","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-medical-devices-insights","tag-public-health","tag-innovative-medical-devices","tag-guideline","tag-software-as-a-medical-device-samd","tag-ai-enabled-devices"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Finalizes Guidance on AI-Enabled Device Updates | RegASK<\/title>\n<meta name=\"description\" content=\"FDA issues final guidance on Predetermined Change Control Plans for AI-enabled devices. 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