{"id":11760,"date":"2015-08-28T06:00:46","date_gmt":"2015-08-28T04:00:46","guid":{"rendered":"https:\/\/www.johner-institut.de\/blog\/?p=11760"},"modified":"2026-02-13T08:47:17","modified_gmt":"2026-02-13T07:47:17","slug":"fda-refuse-to-accept-policy","status":"publish","type":"post","link":"https:\/\/www.johner-institut.de\/blog\/regulatory-affairs\/fda-refuse-to-accept-policy\/","title":{"rendered":"FDA aktualisiert „Refuse to Accept Policy“ f\u00fcr 510(k)"},"content":{"rendered":"

Unter der „Refuse to Accept Policy“ der FDA versteht man einen Kriterienkatalog, anhand dessen die FDA 510(k) Antr\u00e4ge\u00a0bewertet und ggf. zur\u00fcckweist. Diese\u00a0„Refuse to Accept Policy“ hat die FDA im August 2015 aktualisiert.
\n<\/p>\n

Hintergrund und Ziel der „Refuse to Accept Policies“ im Allgemeinen<\/h2>\n

Es gab zahlreiche vergleichbarer Kriterienkataloge, die die FDA mit der neuen Leitlinie<\/a> konsolidiert hat.<\/p>\n

Das Ziel dieser Leitlinie bzw. dieses Kriterienkatalogs besteht darin, die Antr\u00e4ge auf formale<\/strong> Korrektheit zu pr\u00fcfen. Es geht nicht darum festzulegen, ob ein Antrag inhaltlich korrekt ist beispielsweise, ob\u00a0das Predicate Device als wirklich ausreichend \u00e4quivalent betrachtet wird. F\u00fcr diese initiale Pr\u00fcfung nimmt sich die FDA 15 Tage Zeit. Dieser Pr\u00fcfung sollen die Leitlinien dienen.<\/p>\n

\u00c4nderungen<\/h2>\n

Ziel der \u00c4nderungen<\/h3>\n

Die FDA selbst sagt in diesem Dokument, dass die \u00c4nderungen in ihren „Refuse to Accept Policies“ mit folgendem\u00a0\u00a0Ziel erfolgt seien:<\/p>\n

„Enhance the consistency of acceptance decisions and to help submitters better understand the types of information FDA needs to conduct a substantive review [and] clarify the necessary elements and contents of a complete 510(k) submission.<\/p>\n

Inhalt der \u00c4nderungen<\/h3>\n

Die meisten \u00c4nderungen betreffen die zahlreichen Checklisten in den Anh\u00e4ngen. Diese sollen nun vollst\u00e4ndiger, konsistenter aber gleichzeitig auch flexibler auf die jeweilige Situation des Herstellers anwendbar sein. Bemerkenswerterweise sind auch Elemente in Checklisten gel\u00f6scht oder\/und in andere Listen verschoben worden.<\/p>\n

\"Inhalt<\/p>\n

Die Checklisten-Punkte selbst verweisen tw. wieder auf andere FDA Guidane-Dokumente<\/a> z.B. bei Software.<\/p>\n

\"Die<\/p>\n

\n
\"Prof.<\/div>\n
\n
W\u00fcnschen Sie Unterst\u00fctzung beim Einreichen Ihrer Unterlagen, um sicher zu sein, dass Ihr 510(k)-Antrag schnell und sicher „durchgeht“? Professor Johner und sein Team helfen gerne! Nehmen Sie Kontakt auf!<\/div>\n
Kontakt aufnehmen<\/a><\/div>\n<\/div>\n
<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Unter der „Refuse to Accept Policy“ der FDA versteht man einen Kriterienkatalog, anhand dessen die FDA 510(k) Antr\u00e4ge\u00a0bewertet und ggf. zur\u00fcckweist. Diese\u00a0„Refuse to Accept Policy“ hat die FDA im August 2015 aktualisiert.<\/p>\n","protected":false},"author":110,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":true,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[1108],"tags":[1188],"ppma_author":[1251],"class_list":["post-11760","post","type-post","status-publish","format-standard","hentry","category-regulatory-affairs","tag-fda","category-1108","description-off"],"yoast_head":"\n"Refuse to Accept Policy" f\u00fcr 510(k) ~ FDA 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Nutzen\u2026","rel":"","context":"In "Risikomanagement & ISO 14971"","block_context":{"text":"Risikomanagement & ISO 14971","link":"https:\/\/www.johner-institut.de\/blog\/category\/iso-14971-risikomanagement\/"},"img":{"alt_text":"FDA Guidance Dokument: Benefit-Risk-Determination (Nutzen-Risiko-Bewertung)","src":"https:\/\/i0.wp.com\/www.johner-institut.de\/blog\/wp-content\/uploads\/2017\/01\/Risk-Benefit-Analysis.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.johner-institut.de\/blog\/wp-content\/uploads\/2017\/01\/Risk-Benefit-Analysis.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.johner-institut.de\/blog\/wp-content\/uploads\/2017\/01\/Risk-Benefit-Analysis.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.johner-institut.de\/blog\/wp-content\/uploads\/2017\/01\/Risk-Benefit-Analysis.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.johner-institut.de\/blog\/wp-content\/uploads\/2017\/01\/Risk-Benefit-Analysis.png?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/www.johner-institut.de\/blog\/wp-content\/uploads\/2017\/01\/Risk-Benefit-Analysis.png?resize=1400%2C800&ssl=1 4x"},"classes":[]}],"jetpack_shortlink":"https:\/\/wp.me\/pavawf-33G","jetpack_sharing_enabled":true,"authors":[{"term_id":1251,"user_id":110,"is_guest":0,"slug":"katharina-keutgen","display_name":"Katharina Keutgen","avatar_url":{"url":"https:\/\/www.johner-institut.de\/blog\/wp-content\/uploads\/2024\/05\/Katharina_Keutgen_300x300.png","url2x":"https:\/\/www.johner-institut.de\/blog\/wp-content\/uploads\/2024\/05\/Katharina_Keutgen_300x300.png"},"0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":"","9":""}],"_links":{"self":[{"href":"https:\/\/www.johner-institut.de\/blog\/wp-json\/wp\/v2\/posts\/11760","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.johner-institut.de\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.johner-institut.de\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.johner-institut.de\/blog\/wp-json\/wp\/v2\/users\/110"}],"replies":[{"embeddable":true,"href":"https:\/\/www.johner-institut.de\/blog\/wp-json\/wp\/v2\/comments?post=11760"}],"version-history":[{"count":1,"href":"https:\/\/www.johner-institut.de\/blog\/wp-json\/wp\/v2\/posts\/11760\/revisions"}],"predecessor-version":[{"id":4316611,"href":"https:\/\/www.johner-institut.de\/blog\/wp-json\/wp\/v2\/posts\/11760\/revisions\/4316611"}],"wp:attachment":[{"href":"https:\/\/www.johner-institut.de\/blog\/wp-json\/wp\/v2\/media?parent=11760"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.johner-institut.de\/blog\/wp-json\/wp\/v2\/categories?post=11760"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.johner-institut.de\/blog\/wp-json\/wp\/v2\/tags?post=11760"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/www.johner-institut.de\/blog\/wp-json\/wp\/v2\/ppma_author?post=11760"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}