{"id":33186,"date":"2024-10-18T11:20:38","date_gmt":"2024-10-18T09:20:38","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/10\/18\/aggiornamenti-sul-programma-asca-tre-bozze-di-linee-guida-fda\/"},"modified":"2024-10-18T14:16:52","modified_gmt":"2024-10-18T12:16:52","slug":"aggiornamenti-sul-programma-asca-tre-bozze-di-linee-guida-fda","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/10\/18\/aggiornamenti-sul-programma-asca-tre-bozze-di-linee-guida-fda\/","title":{"rendered":"Actualizaciones del programa ASCA: tres proyectos de directrices de la FDA"},"content":{"rendered":"<p style=\"text-align: right;\">18\/10\/2024<\/p>\n<h2>El 15 de septiembre de 2024, la FDA actualiz\u00f3 tres proyectos de directrices relacionadas con <strong>ASCA (Basic Safety and Essential Performance)<\/strong>, un <strong>programa voluntario<\/strong> que permite a los fabricantes de productos sanitarios utilizar laboratorios acreditados por ASCA para realizar pruebas que deben incluirse en las solicitudes previas a la comercializaci\u00f3n para acceder al mercado estadounidense.<\/h2>\n<h2><strong>Objetivos del Programa ASCA<\/strong><\/h2>\n<p>ASCA est\u00e1 dise\u00f1ado para simplificar la documentaci\u00f3n necesaria para demostrar la conformidad mediante el uso de <strong>los informes de ensayo resumidos ASCA<\/strong>. Las directrices pretenden transformar el ASCA de una iniciativa piloto a un programa permanente, introduciendo mejoras basadas en las reacciones recibidas durante la fase piloto y en el compromiso de la agencia recogido en la Medical Device User Fee Amendments 2022 (MDUFA V).<\/p>\n<p>Las directrices reflejan las actualizaciones de las reuniones, seminarios web y encuentros con las partes interesadas, as\u00ed como las lecciones aprendidas durante la <strong>fase piloto<\/strong>. Una vez definitivas, estas directrices sustituir\u00e1n a las tres directrices piloto ASCA publicadas el 25 de septiembre de 2020. Para participar en el programa, los fabricantes deben presentar una notificaci\u00f3n previa a la comercializaci\u00f3n (510(k)) a la FDA, que debe incluir datos e informaci\u00f3n que demuestren el cumplimiento de <strong>los requisitos del programa<\/strong>.<\/p>\n<h2><strong>Resumen de las directrices actualizadas<\/strong><\/h2>\n<ul>\n<li><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/accreditation-scheme-conformity-assessment-asca-program\"><strong><em>The Accreditation Scheme for Conformity Assessment (ASCA) Program<\/em><\/strong><\/a><strong><em>:<br \/>\n<\/em><\/strong><strong>El Programa ASCA de evaluaci\u00f3n de la conformidad &#8211; <\/strong>la presente directriz esboza los objetivos y procedimientos del programa, destacando la importancia de un marco adecuado para apoyar los esfuerzos de la agencia en el uso eficiente de los recursos cient\u00edficos en beneficio de la salud p\u00fablica.<\/li>\n<li><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/biocompatibility-testing-medical-devices-standards-specific-information-accreditation-scheme-0\"><strong><em>Biocompatibility Testing of Medical Devices \u2013 Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program:<\/em><\/strong><\/a><strong><em><br \/>\n<\/em><\/strong><strong>Pruebas de biocompatibilidad de productos sanitarios<\/strong> &#8211; esta gu\u00eda proporciona detalles sobre c\u00f3mo se integran las normas de evaluaci\u00f3n biol\u00f3gica en el programa ASCA. El nuevo borrador consta de 168 p\u00e1ginas, lo que supone un aumento de m\u00e1s de 100 en comparaci\u00f3n con el documento anterior, y ofrece informaci\u00f3n m\u00e1s detallada sobre m\u00e9todos de ensayo, especificaciones ASCA e informes resumidos. Incluye nuevas secciones sobre los requisitos de competencia de los asesores t\u00e9cnicos de los organismos de acreditaci\u00f3n, el alcance de la acreditaci\u00f3n ASCA y recomendaciones para los laboratorios de ensayo. La gu\u00eda hace hincapi\u00e9 en la importancia de demostrar la competencia y elaborar planes de pruebas de biocompatibilidad.<\/li>\n<li><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/basic-safety-and-essential-performance-medical-electrical-equipment-medical-electrical-systems-and-0\"><strong><em>Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment \u2013 Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program<\/em><\/strong><\/a><strong><em>:<br \/>\n<\/em><\/strong><strong>Seguridad b\u00e1sica<\/strong> <strong>y funcionamiento esencial<\/strong> <strong>de los dispositivos m\u00e9dicos el\u00e9ctricos y los sistemas de laboratorio &#8211; <\/strong>esta gu\u00eda se centra en la seguridad y el funcionamiento esencial de dichos dispositivos. Ofrece informaci\u00f3n sobre c\u00f3mo se incorporan las normas al programa ASCA, ilustrando la importancia de su cumplimiento para garantizar la seguridad y eficacia de los productos.<\/li>\n<\/ul>\n<p>Aunque las directrices a\u00fan no est\u00e1n terminadas, conviene familiarizarse con ellas, ya que el programa ASCA representa una <strong>importante oportunidad para los fabricantes<\/strong>. Entre sus muchas ventajas, destaca la <strong>reducci\u00f3n de las cargas reglamentarias<\/strong>. Gracias a ASCA, los fabricantes pueden obtener la aprobaci\u00f3n de sus dispositivos <strong>con mayor rapidez<\/strong>. Las directrices se actualizan constantemente en funci\u00f3n de los comentarios de los usuarios, lo que garantiza que sigan siendo pertinentes y \u00fatiles.<\/p>\n<p>En conclusi\u00f3n, el programa ASCA no solo ofrece ventajas pr\u00e1cticas y estrat\u00e9gicas a los fabricantes, sino que tambi\u00e9n representa un paso importante hacia un sistema sanitario m\u00e1s seguro e innovador.<\/p>\n<p><strong>&gt;&gt;&gt; <\/strong>Thema y <a href=\"https:\/\/www.thema-med.com\/en\/usa\/\"><strong>Thema Corp<\/strong><\/a> (con sede en Estados Unidos), est\u00e1n preparadas para ayudar en cada etapa del <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>proceso estrat\u00e9gico y reglamentario<\/strong><\/a> relativo a los productos sanitarios en el mercado estadounidense.<\/p>\n<p><strong>FUENTE:<br \/>\n<\/strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/division-standards-and-conformity-assessment\/accreditation-scheme-conformity-assessment-asca\">https:\/\/www.fda.gov\/medical-devices\/division-standards-and-conformity-assessment\/accreditation-scheme-conformity-assessment-asca<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>18\/10\/2024 El 15 de septiembre de 2024, la FDA actualiz\u00f3 tres proyectos de directrices relacionadas con ASCA (Basic Safety and Essential  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":33162,"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-33186","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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