{"id":31246,"date":"2023-11-22T15:16:35","date_gmt":"2023-11-22T14:16:35","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=31246"},"modified":"2023-11-23T11:35:48","modified_gmt":"2023-11-23T10:35:48","slug":"ee-uu-inspecciones-fda-a-fabricantes-previstas-a-partir-de-enero-de-2024","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2023\/11\/22\/ee-uu-inspecciones-fda-a-fabricantes-previstas-a-partir-de-enero-de-2024\/","title":{"rendered":"EE.UU.: Inspecciones FDA a fabricantes previstas a partir de enero de 2024"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container 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-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;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_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2>El pasado mes de octubre de 2023, la Food and Drug Administration (FDA) actualiz\u00f3 en su p\u00e1gina web oficial el <a href=\"https:\/\/www.fda.gov\/media\/80195\/download\"><em>Compliance Program Manual<\/em><\/a> que contempla las <strong>inspecciones <\/strong>de los fabricantes de productos sanitarios con el fin de promover y mejorar continuamente la calidad, seguridad y eficacia de los productos y as\u00ed satisfacer las necesidades de los pacientes y salvaguardar su salud.<\/h2>\n<p>El <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:22017D0382&amp;qid=1696584999388\">Mutual Recognition Agreement<\/a> (MRA) entre la Comisi\u00f3n Europea y la FDA pretende reconocer mutuamente los sistemas de inspecci\u00f3n de buenas pr\u00e1cticas de fabricaci\u00f3n (<strong>BPF<\/strong>) y reducir el n\u00famero de inspecciones. Sin embargo, un acuerdo de este tipo no garantiza que no hayan <strong>controles rec\u00edprocos<\/strong>, sobre todo teniendo en cuenta los problemas que la FDA ha encontrado en los \u00faltimos a\u00f1os durante las inspecciones de los centros de producci\u00f3n en Europa. Por ejemplo, se detectaron <strong>incoherencias y<\/strong> <strong>falta<\/strong> de informaci\u00f3n en el informe de inspecci\u00f3n y falta de calidad durante la vigilancia posterior a la comercializaci\u00f3n, lo que suscit\u00f3 preocupaci\u00f3n sobre la calidad de los productos o la seguridad de los pacientes. Precisamente por estas razones, la FDA ha decidido aumentar las inspecciones de los fabricantes europeos en determinados pa\u00edses, entre ellos Italia, a partir de <strong>enero de 2024<\/strong>.<\/p>\n<p>El programa actualizado tiene por objeto <strong>orientar<\/strong> al personal de la FDA en la realizaci\u00f3n de inspecciones de los fabricantes de dispositivos para identificar a los que no cumplen con la normativa y lograr que estas organizaciones garanticen su conformidad por medios voluntarios, administrativos y\/o reglamentarios, seg\u00fan proceda.<\/p>\n<p>Los inspectores de la FDA deben inspeccionar a los fabricantes de dispositivos de clase II y clase III utilizando una metodolog\u00eda <strong>basada en el riesgo<\/strong>. En concreto, se llevar\u00e1n a cabo inspecciones <strong>previas a la comercializaci\u00f3n<\/strong> en virtud de los <em>Medical Device User Fee Amendments (MDUFA)<\/em>, se inspeccionar\u00e1n a los fabricantes de dispositivos <strong>implantables<\/strong> y de <strong>clase<\/strong> III que nunca hayan sido inspeccionados, a los fabricantes de dispositivos con una mayor frecuencia de <strong>retiradas del mercado<\/strong> y a los fabricantes de dispositivos reci\u00e9n introducidos en el mercado con <strong>recientes autorizaciones 510(k) y De Novo<\/strong>.<\/p>\n<p>Este programa de cumplimiento tambi\u00e9n proporciona instrucciones espec\u00edficas para el seguimiento, as\u00ed como para el registro y la entrada en la base <strong>GUDID<\/strong>.<\/p>\n<p>La FDA tambi\u00e9n pone a disposici\u00f3n el <a href=\"https:\/\/datadashboard.fda.gov\/ora\/cd\/inspections.htm\"><strong>Dashboard<\/strong><\/a>, que ofrece una visi\u00f3n detallada de sus <strong>actividades<\/strong> mediante tablas y gr\u00e1ficos f\u00e1ciles de usar y comprensibles para un an\u00e1lisis exhaustivo. Seg\u00fan los cuadros y gr\u00e1ficos mostrados, <strong>en 2023 y 2022 solo 20 y 7 fabricantes italianos de productos sanitarios<\/strong>, respectivamente, se sometieron a inspecciones de la FDA, un n\u00famero muy <strong>reducido<\/strong> en comparaci\u00f3n con otros Estados miembros. En consecuencia, debido a las deficiencias descritas anteriormente, se supone que el n\u00famero de inspecciones de la FDA podr\u00eda al menos duplicarse a partir de enero de 2024.<\/p>\n<p>&gt;&gt; En previsi\u00f3n de las inspecciones de la FDA, Thema puede realizar un an\u00e1lisis de las deficiencias del sistema de gesti\u00f3n de la calidad en conformidad con la norma <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/qualita-e-gmp-internazionali\/\"><strong>21 CFR 820<\/strong><\/a> <em>et alter<\/em>, puede asistir al fabricante durante la auditor\u00eda y ser de apoyo en la fase posterior a la inspecci\u00f3n para la resoluci\u00f3n de cualquier <em>deficiencia<\/em>.<\/p>\n<p>Adem\u00e1s, a trav\u00e9s de los servicios de\u00a0<a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\"><strong>consultor\u00eda estrat\u00e9gica-normativa<\/strong><\/a> y redacci\u00f3n de <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/registrazioni-internazionali-extra-ue-dispositivi-medici-dm-e-medico-diagnostici-in-vitro-ivd\/\"><strong>notificaciones previas a la comercializaci\u00f3n 510(k), De Novo y aprobaci\u00f3n previa a la comercializaci\u00f3n (PMA)<\/strong><\/a> Thema puede apoyarle para comercializar productos sanitarios en los EE.UU. cumpliendo con los requisitos de la Administraci\u00f3n de Alimentos y Medicamentos (FDA).<\/p>\n<p><strong>Fuente<\/strong><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/media\/80195\/download\">Compliance Program Manual<\/a><\/p>\n<p><a href=\"https:\/\/datadashboard.fda.gov\/ora\/cd\/inspections.htm\">Dashboard<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":31230,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-31246","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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