{"id":779,"date":"2024-06-17T16:12:47","date_gmt":"2024-06-17T16:12:47","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?page_id=779"},"modified":"2026-01-21T09:36:36","modified_gmt":"2026-01-21T09:36:36","slug":"usa-fda-agent","status":"publish","type":"page","link":"https:\/\/cmcmedicaldevices.com\/es\/regiones\/usa-fda-agent\/","title":{"rendered":"USA &#8211; FDA Agent"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background fusion-parallax-none nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:150px;--awb-padding-bottom:85px;--awb-background-color:var(--awb-color5);--awb-background-image:linear-gradient(168deg, rgba(6,43,33,0.96) 0%,rgba(6,43,33,0.13) 100%),url(https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/06\/new-york-city-manhattan-skyline-3000x1684.webp);;--awb-background-size:cover;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-center fusion-flex-justify-content-space-between fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_3_5 3_5 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:60%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.2%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:3.2%;--awb-width-medium:60%;--awb-order-medium:0;--awb-spacing-right-medium:3.2%;--awb-spacing-left-medium:3.2%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-image-element \" style=\"--awb-margin-bottom:10px;--awb-max-width:30px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none fusion-animated\" data-animationType=\"rubberBand\" data-animationDuration=\"0.6\" data-animationOffset=\"top-into-view\"><img decoding=\"async\" width=\"2560\" height=\"2477\" title=\"ISOTIPO CMC MEDICAL DEVICES_AZUL\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-scaled.webp\" alt class=\"img-responsive wp-image-17\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-200x194.webp 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-400x387.webp 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-600x581.webp 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-768x743.webp 768w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-800x774.webp 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-1200x1161.webp 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-1536x1486.webp 1536w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/04\/ISOTIPO-CMC-MEDICAL-DEVICES_AZUL-scaled.webp 2560w\" sizes=\"(max-width: 640px) 100vw, 800px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-one fusion-animated\" style=\"--awb-text-color:var(--awb-color3);--awb-font-size:20px;\" data-animationType=\"fadeInDown\" data-animationDuration=\"0.6\" data-animationOffset=\"top-into-view\"><h1 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Merriweather Sans&quot;;font-style:normal;font-weight:300;margin:0;font-size:1em;text-transform:uppercase;--fontSize:20;--minFontSize:20;line-height:var(--awb-typography1-line-height);\">USA | FDA Agent<\/h1><\/div><div class=\"fusion-title title fusion-title-2 fusion-sep-none fusion-title-text fusion-title-size-two fusion-animated\" style=\"--awb-text-color:var(--awb-color4);--awb-margin-right:10%;--awb-margin-bottom:20px;\" data-animationType=\"fadeInDown\" data-animationDuration=\"0.6\" data-animationOffset=\"top-into-view\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:40;line-height:var(--awb-typography1-line-height);\"><div class=\"page\" title=\"Page 2\">\n<div class=\"section\">\n<div class=\"layoutArea\">\n<div class=\"column\">Tu agente FDA en los Estados Unidos<\/div>\n<\/div>\n<\/div>\n<\/div><\/h2><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:50px;--awb-padding-bottom:80px;--awb-background-color:var(--awb-color4);--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-justify-content-space-between fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_4_5 4_5 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:80%;--awb-margin-top-large:30px;--awb-spacing-right-large:2.4%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:2.4%;--awb-width-medium:80%;--awb-order-medium:0;--awb-margin-top-medium:5px;--awb-spacing-right-medium:2.4%;--awb-spacing-left-medium:2.4%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-3 fusion-sep-none fusion-title-text fusion-title-size-four\" style=\"--awb-margin-bottom:40px;--awb-margin-bottom-small:30px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:24;line-height:var(--awb-typography1-line-height);\">Garantizamos que sus productos sanitarios cumplan con las normativas de la FDA, asegurando un acceso r\u00e1pido y seguro al mercado estadounidense.<\/h4><\/div><div class=\"fusion-separator\" style=\"align-self: flex-start;margin-right:auto;margin-bottom:50px;width:100%;max-width:200px;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-1\"><p>en CMC Medical Devices LLC, ayudamos a todos los fabricantes de productos sanitarios y IVD que no tengan su sede en EE.UU, su <strong><u><a href=\"https:\/\/cmcmedicaldevices.com\/es\/servicios\/representacion-usa\/\">agente exclusivo de la FDA<\/a><\/u><\/strong>, brindando orientaci\u00f3n experta durante todo el proceso regulatorio y actuando como intermediario que conecta a su empresa con la FDA.<\/p>\n<p>CMC brinda asistencia con el proceso completo de <strong><u><a href=\"https:\/\/cmcmedicaldevices.com\/es\/servicios\/representacion-usa\/\">registro de la FDA<\/a><\/u><\/strong>, garantizando que sus productos cumplan con todos los est\u00e1ndares regulatorios.<\/p>\n<\/div><div ><a class=\"fusion-button button-flat fusion-button-default-size button-custom fusion-button-default button-1 fusion-button-default-span fusion-button-default-type awb-b-icon-pos-right\" style=\"--button_accent_color:var(--awb-color5);--button_border_color:var(--awb-color4);--button_accent_hover_color:var(--awb-color5);--button_border_hover_color:var(--awb-color5);--button_gradient_top_color:rgba(0,0,0,0);--button_gradient_bottom_color:rgba(0,0,0,0);--button_gradient_top_color_hover:rgba(0,0,0,0);--button_gradient_bottom_color_hover:rgba(0,0,0,0);--button_font_size:16px;--button_padding-left:8px;--button_typography-font-family:&quot;Merriweather Sans&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;\" target=\"_self\" data-hover=\"icon_position\" href=\"https:\/\/cmcmedicaldevices.com\/es\/contacto\/\"><span class=\"fusion-button-text\">Contacta con nosotros<\/span><i class=\"fa-angle-right fas button-icon-right\" aria-hidden=\"true\"><\/i><i class=\"fa-angle-right fas button-icon-right\" aria-hidden=\"true\"><\/i><\/a><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-3 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-sizes-bottom:1px;--awb-border-color:rgba(197,252,84,0.5);--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:90px;--awb-padding-bottom:90px;--awb-background-color:var(--awb-color5);--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:9.6%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:3.84%;--awb-width-medium:50%;--awb-order-medium:0;--awb-spacing-right-medium:9.6%;--awb-spacing-left-medium:3.84%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-margin-bottom-small:65px;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-4 fusion-sep-none fusion-title-text fusion-title-size-three\" style=\"--awb-text-color:var(--awb-color3);--awb-margin-bottom:30px;--awb-margin-bottom-small:20px;\"><h3 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:32;line-height:1.4;\">510(K)<\/h3><\/div><div class=\"fusion-title title fusion-title-5 fusion-sep-none fusion-title-text fusion-title-size-six\" style=\"--awb-text-color:var(--awb-color4);--awb-margin-bottom:20px;\"><h6 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Merriweather&quot;;font-style:normal;font-weight:400;margin:0;--fontSize:16;--minFontSize:16;line-height:var(--awb-typography1-line-height);\"><p class=\"p1\">Si necesita presentar una solicitud 510(k) en EE.UU., CMC puede ayudarle. Estamos especializados en guiar a los fabricantes de productos sanitarios a trav\u00e9s del proceso de presentaci\u00f3n ante la FDA.<\/p><\/h6><\/div><div ><a class=\"fusion-button button-flat fusion-button-default-size button-custom fusion-button-default button-2 fusion-button-default-span fusion-button-default-type awb-b-icon-pos-right\" style=\"--button_accent_color:var(--awb-color3);--button_border_color:var(--awb-color4);--button_accent_hover_color:var(--awb-color3);--button_border_hover_color:var(--awb-color3);--button_gradient_top_color:rgba(0,0,0,0);--button_gradient_bottom_color:rgba(0,0,0,0);--button_gradient_top_color_hover:rgba(0,0,0,0);--button_gradient_bottom_color_hover:rgba(0,0,0,0);--button_font_size:16px;--button_padding-left:8px;--button_typography-font-family:&quot;Merriweather Sans&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;\" target=\"_self\" data-hover=\"icon_position\" href=\"https:\/\/cmcmedicaldevices.com\/es\/contacto\/\"><span class=\"fusion-button-text\">Presentamos tu solicitud 510(K) en EEUU<\/span><i class=\"fa-angle-right fas button-icon-right\" aria-hidden=\"true\"><\/i><i class=\"fa-angle-right fas button-icon-right\" aria-hidden=\"true\"><\/i><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:9.6%;--awb-width-medium:50%;--awb-order-medium:0;--awb-spacing-right-medium:3.84%;--awb-spacing-left-medium:9.6%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-6 fusion-sep-none fusion-title-text fusion-title-size-three\" style=\"--awb-text-color:var(--awb-color3);--awb-margin-bottom:30px;--awb-margin-bottom-small:20px;\"><h3 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:32;line-height:1.4;\">UK FSC<\/h3><\/div><div class=\"fusion-title title fusion-title-7 fusion-sep-none fusion-title-text fusion-title-size-six\" style=\"--awb-text-color:var(--awb-color4);--awb-margin-bottom:20px;\"><h6 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Merriweather&quot;;font-style:normal;font-weight:400;margin:0;--fontSize:16;--minFontSize:16;line-height:var(--awb-typography1-line-height);\"><p class=\"p1\">CMC tambi\u00e9n puede solicitar el FSC de USA para cualquier pa\u00eds del mundo, incluyendo la legalizaci\u00f3n del pa\u00eds correspondiente.<\/p><\/h6><\/div><div ><a class=\"fusion-button button-flat fusion-button-default-size button-custom fusion-button-default button-3 fusion-button-default-span fusion-button-default-type awb-b-icon-pos-right\" style=\"--button_accent_color:var(--awb-color3);--button_border_color:var(--awb-color4);--button_accent_hover_color:var(--awb-color3);--button_border_hover_color:var(--awb-color3);--button_gradient_top_color:rgba(0,0,0,0);--button_gradient_bottom_color:rgba(0,0,0,0);--button_gradient_top_color_hover:rgba(0,0,0,0);--button_gradient_bottom_color_hover:rgba(0,0,0,0);--button_font_size:16px;--button_padding-left:8px;--button_typography-font-family:&quot;Merriweather Sans&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;\" target=\"_self\" data-hover=\"icon_position\" href=\"https:\/\/cmcmedicaldevices.com\/es\/contacto\/\"><span class=\"fusion-button-text\">Registramos tus productos en USA<\/span><i class=\"fa-angle-right fas button-icon-right\" aria-hidden=\"true\"><\/i><i class=\"fa-angle-right fas button-icon-right\" aria-hidden=\"true\"><\/i><\/a><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":634,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-779","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>USA - FDA Agent | CMC Medical Devices<\/title>\n<meta name=\"description\" content=\"Servicios de representaci\u00f3n para dispositivos m\u00e9dicos en EE.UU. 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