{"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":"fda-leitfaden-fur-ki-gerate-pccp","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/fda-ai-device-guidance-pccp\/","title":{"rendered":"FDA (USA) gibt endg\u00fcltige Leitlinien zu vorbestimmten \u00c4nderungen heraus \u2026"},"content":{"rendered":"<p>Am 4. Dezember 2024 ver\u00f6ffentlichte die US-amerikanische Food and Drug Administration (FDA) ihre endg\u00fcltige Richtlinie. <strong>\u201eEmpfehlungen f\u00fcr die Marketingeinreichung eines vorgegebenen \u00c4nderungskontrollplans f\u00fcr Ger\u00e4tesoftwarefunktionen mit k\u00fcnstlicher Intelligenz.\u201c<\/strong> Dieses Update stellt einen wichtigen Fortschritt in der <a href=\"https:\/\/regask.com\/de\/fda-leitfaden-fur-covid-19-medizinprodukte\/\">Der regulatorische Rahmen der FDA<\/a>, entwickelt, um kontinuierliche Innovationen bei KI-f\u00e4higen medizinischen Ger\u00e4ten zu unterst\u00fctzen und gleichzeitig deren Sicherheit und Wirksamkeit zu gew\u00e4hrleisten.<\/p>\n<p>Die Leitlinien f\u00fchren das Konzept einer <strong>Vordefinierter \u00c4nderungskontrollplan (PCCP)<\/strong>, in dem geplante \u00c4nderungen an KI-f\u00e4higen Ger\u00e4ten detailliert beschrieben werden. Das PCCP umfasst Methoden zur Entwicklung, Validierung und Implementierung dieser \u00c4nderungen sowie Bewertungen ihrer Auswirkungen auf die Sicherheit und Wirksamkeit des Ger\u00e4ts.<\/p>\n<p><strong>Wichtige Highlights:<\/strong><\/p>\n<ul>\n<li><strong>Anwendungsbereich:<\/strong><br \/>\nDie Leitlinien gelten f\u00fcr KI-f\u00e4hige Ger\u00e4te verschiedener Produktkategorien, einschlie\u00dflich derjenigen, die im Rahmen der 510(k)-Vormarktbenachrichtigung, der De-novo-Klassifizierungsanfrage und der Vormarktzulassung (PMA) gepr\u00fcft werden. Sie umfassen auch Ger\u00e4tekomponenten ger\u00e4tebasierter Kombinationsprodukte.<\/li>\n<li><strong>\u00dcberpr\u00fcfungsprozess:<\/strong><br \/>\nDie FDA pr\u00fcft den PCCP im Rahmen der Zulassungsanmeldung des Ger\u00e4ts und stellt sicher, dass die geplanten \u00c4nderungen den Sicherheits- und Wirksamkeitsstandards entsprechen. Dadurch entf\u00e4llt die Notwendigkeit neuer Zulassungsantr\u00e4ge f\u00fcr jede im PCCP aufgef\u00fchrte \u00c4nderung.<\/li>\n<li><strong>\u00d6ffentliche Kommentare und Updates:<\/strong><br \/>\nDie \u00dcberarbeitungen der Leitlinien spiegeln das Feedback aus \u00f6ffentlichen Kommentaren wider, einschlie\u00dflich Klarstellungen zum Umfang, den Kennzeichnungsanforderungen, den Implementierungsprozessen im Rahmen eines autorisierten PCCP und Empfehlungen zur \u00dcberwachung nach dem Inverkehrbringen. Die Definitionen von \u201ek\u00fcnstlicher Intelligenz\u201c und \u201emaschinellem Lernen\u201c wurden aktualisiert, um sie an <strong>Durchf\u00fchrungsverordnung 14110<\/strong> herausgegeben am 30. Oktober 2023.<\/li>\n<\/ul>\n<p>Diese Leitlinien stellen einen Meilenstein in der Regulierungspraxis f\u00fcr KI-f\u00e4hige Ger\u00e4te dar und schaffen ein Gleichgewicht zwischen Innovation und den Priorit\u00e4ten der \u00f6ffentlichen Gesundheit.<\/p>\n<p>F\u00fcr weitere Informationen oder um Compliance-Strategien zu besprechen, kontaktieren Sie uns bitte.<\/p>","protected":false},"excerpt":{"rendered":"<p>Am 4. Dezember 2024 ver\u00f6ffentlichte die US-amerikanische Arzneimittelbeh\u00f6rde FDA ihre endg\u00fcltige Leitlinie \u201cEmpfehlungen f\u00fcr die Markteinf\u00fchrung eines vorab festgelegten \u00c4nderungskontrollplans f\u00fcr KI-gest\u00fctzte Ger\u00e4te-Softwarefunktionen\u201d. Diese Aktualisierung stellt einen wichtigen Fortschritt im regulatorischen Rahmen der FDA dar und soll kontinuierliche Innovationen bei KI-gest\u00fctzten Medizinprodukten f\u00f6rdern und gleichzeitig deren Sicherheit gew\u00e4hrleisten.<\/p>","protected":false},"author":30,"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 v27.3 (Yoast SEO v27.5) - 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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