{"id":95,"date":"2021-03-24T09:41:24","date_gmt":"2021-03-24T08:41:24","guid":{"rendered":"http:\/\/www.meliora-compliance.com\/?page_id=95"},"modified":"2023-09-20T21:13:03","modified_gmt":"2023-09-20T19:13:03","slug":"us-fda-clearance-and-approval","status":"publish","type":"page","link":"https:\/\/www.meliora-compliance.com\/czech\/us-fda-clearance-and-approval\/","title":{"rendered":"Schv\u00e1len\u00ed pro USA"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"95\" class=\"elementor elementor-95\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-55467e8c elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"55467e8c\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;shape_divider_bottom&quot;:&quot;triangle&quot;,&quot;shape_divider_bottom_negative&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t<div class=\"elementor-shape elementor-shape-bottom\" data-negative=\"true\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 1000 100\" preserveaspectratio=\"none\">\n\t<path class=\"elementor-shape-fill\" d=\"M500.2,94.7L0,0v100h1000V0L500.2,94.7z\"\/>\n<\/svg>\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-309d6d24\" data-id=\"309d6d24\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-93476b0 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"93476b0\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/09\/fda-300x300.png\" class=\"elementor-animation-push attachment-medium size-medium wp-image-1311\" alt=\"\" srcset=\"https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/09\/fda-300x300.png 300w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/09\/fda-150x150.png 150w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/09\/fda-12x12.png 12w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/09\/fda.png 512w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-74242596\" data-id=\"74242596\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4f89e1c6 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"4f89e1c6\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Schv\u00e1len\u00ed pro USA<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-50d0b749 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"50d0b749\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-620f0307\" data-id=\"620f0307\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-77f8b99d elementor-widget elementor-widget-heading\" data-id=\"77f8b99d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Chcete vstoupit na trh v USA?<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-859cb07 elementor-widget elementor-widget-text-editor\" data-id=\"859cb07\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">USA jsou nejv\u011bt\u0161\u00edm sv\u011btov\u00fdm trhem se zdravotnick\u00fdmi prost\u0159edky. Prost\u0159edky prod\u00e1van\u00e9 ve Spojen\u00fdch st\u00e1tech podl\u00e9haj\u00ed regulatorn\u00edm po\u017eadavk\u016fm Feder\u00e1ln\u00edho \u00fa\u0159adu pro potraviny a l\u00e9\u010diva (FDA). Se zam\u011b\u0159en\u00edm na v\u00fdrobce v EU, kte\u0159\u00ed maj\u00ed v \u00famyslu prod\u00e1vat v USA, v\u00e1m Meliora Compliance pom\u016f\u017ee z\u00edskat regulatorn\u00ed schv\u00e1len\u00ed pro v\u00e1\u0161 prost\u0159edek v USA.<\/span><\/p><p><span style=\"font-weight: 400;\">Nab\u00edz\u00edme tyto slu\u017eby:<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-257817ce elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"257817ce\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6743100a\" data-id=\"6743100a\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-14e6dc03 elementor-widget elementor-widget-text-editor\" data-id=\"14e6dc03\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">P\u0159\u00edprava regulatorn\u00ed strategie pro USA<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Implementace nebo \u00faprava va\u0161eho syst\u00e9mu jakosti tak, aby byl v souladu s na\u0159\u00edzen\u00edm FDA QS (21 CFR Part 820) a Programem jednotn\u00e9ho auditu zdravotnick\u00fdch prost\u0159edk\u016f (MDSAP).<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Spolupr\u00e1ce s va\u0161\u00edm v\u00fdvojov\u00fdm t\u00fdmem na zaji\u0161t\u011bn\u00ed toho, aby v\u00fdvojov\u00e9 \u010dinnosti, v\u010detn\u011b testov\u00e1n\u00ed n\u00e1vrhu, byly prov\u00e1d\u011bny v souladu s US normami a dal\u0161\u00edmi platn\u00fdmi po\u017eadavky.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">P\u0159\u00edprava 513 (g) \u017d\u00e1dosti o informace pro klasifikaci (Request for Information)\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">P\u0159\u00edprava p\u0159edb\u011b\u017en\u00e9 \u017e\u00e1dosti (pre-submission) a \u00fa\u010dast na n\u00e1sledn\u00fdch sch\u016fzk\u00e1ch s FDA<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">P\u0159\u00edprava \u017e\u00e1dosti IDE (Investigational Device Exemption) pro schv\u00e1len\u00ed klinick\u00fdch studi\u00ed v USA<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">P\u0159\u00edprava \u017e\u00e1dosti za \u00fa\u010delem ur\u010den\u00ed pr\u016flomov\u00e9ho zdravotnick\u00e9ho prost\u0159edku (Breakthrough Device designation)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">P\u0159\u00edprava \u017e\u00e1dosti o vstup do programu Safer Technologies (STeP)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Vypracov\u00e1n\u00ed strategie pro zaveden\u00ed v\u00fdznamn\u00e9 podobnosti (SE) pro zdravotnick\u00e9 prost\u0159edky, kter\u00e9 vy\u017eaduj\u00ed pod\u00e1n\u00ed \u017e\u00e1dosti 510(k)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Vytvo\u0159en\u00ed \u017e\u00e1dosti 510(k) pro z\u00edsk\u00e1n\u00ed schv\u00e1len\u00ed prost\u0159edku \u00fa\u0159adem FDA<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">P\u0159\u00edprava a pod\u00e1n\u00ed \u017e\u00e1dosti o klasifikaci podle De Novo programu<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Vytvo\u0159en\u00ed a p\u0159edlo\u017een\u00ed \u017e\u00e1dosti pro schv\u00e1len\u00ed prost\u0159edk\u016f vy\u0161\u0161\u00edch t\u0159\u00edd (PMA)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Vytvo\u0159en\u00ed \u017e\u00e1dosti Humanitarian Use Device (HUD) \/ Humanitarian Device Exemption (HDE)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Revize n\u00e1vodu k pou\u017eit\u00ed, revize ozna\u010den\u00ed na v\u00fdrobku (\u0161t\u00edtk\u016f) a marketingov\u00e9 dokumentace, aby byla zaji\u0161t\u011bna shoda s platn\u00fdmi regulatorn\u00edmi po\u017eadavky<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">V\u00fdb\u011br a nasmlouv\u00e1n\u00ed z\u00e1stupce pro v\u00fdrobce se s\u00eddlem mimo USA (US Agent)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0160kolen\u00ed na FDA QSR a na \u017e\u00e1dosti o povolen\u00edch t\u00fdkaj\u00edc\u00edch se zdravotnick\u00fdch prost\u0159edk\u016f v US<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Zastoupen\u00ed v\u00fdrobc\u016f p\u0159i inspekc\u00edch QSR (21 CFR \u010d\u00e1st 820) ze strany FDA<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Anal\u00fdza, odpov\u011b\u010f a n\u00e1pravn\u00e1 opat\u0159en\u00ed vypl\u00fdvaj\u00edc\u00ed z FDA n\u00e1lez\u016f o neshod\u00e1ch (483s a Warning Letters)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Registrace v\u00fdrobce u FDA a vytvo\u0159en\u00ed z\u00e1znamu o prost\u0159edku v FDA datab\u00e1zi (FURLS).<\/span><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-77e45559 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"77e45559\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-fbc7423\" data-id=\"fbc7423\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1d2bcc29 elementor-widget elementor-widget-heading\" data-id=\"1d2bcc29\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-medium\">Dotazy?<br>\nNapi\u0161te n\u00e1m!<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-69d7d5ca elementor-align-center elementor-widget elementor-widget-button\" data-id=\"69d7d5ca\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md\" href=\"https:\/\/www.meliora-compliance.com\/czech\/contact-us\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-right\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-long-arrow-alt-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t<span class=\"elementor-button-text\">Kontakt<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>US FDA clearance and approval Do you intend to sell in US? The US is the world\u2019s largest medical device market. Medical devices marketed in the United States are subject to the regulatory controls by the U.S. Food and Drug Administration (FDA). With the focus on EU manufacturers who intend to sell in US, Meliora &#8230; <a title=\"Schv\u00e1len\u00ed pro USA\" class=\"read-more\" href=\"https:\/\/www.meliora-compliance.com\/czech\/us-fda-clearance-and-approval\/\" aria-label=\"V\u00edce na US FDA clearance and approval\">\u010c\u00edst d\u00e1l<\/a><\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-95","page","type-page","status-publish"],"_links":{"self":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/95","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/comments?post=95"}],"version-history":[{"count":50,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/95\/revisions"}],"predecessor-version":[{"id":1432,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/95\/revisions\/1432"}],"wp:attachment":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/media?parent=95"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}