{"id":5435,"date":"2019-11-01T12:21:40","date_gmt":"2019-11-01T18:21:40","guid":{"rendered":"https:\/\/saluddigital.com\/?p=5435"},"modified":"2025-10-21T16:05:14","modified_gmt":"2025-10-21T22:05:14","slug":"la-fda-avanza-a-pasos-acelerados-en-el-registro-de-soluciones-de-salud-digital","status":"publish","type":"post","link":"https:\/\/saluddigital.com\/en\/avance-de-la-ciencia\/la-fda-avanza-a-pasos-acelerados-en-el-registro-de-soluciones-de-salud-digital\/","title":{"rendered":"The FDA is making rapid progress in registering Digital Health solutions"},"content":{"rendered":"
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Thanks to the Precertification Program that is responsible for regulating food and medicine through software within the US government, several companies obtained the registration of medical devices, algorithms based on artificial intelligence and diagnostic tools.<\/h2>\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<\/div>\n\t\t<\/section>\n\t\t\t\t
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The Food and Drug Administration Agency <\/strong>(FDA) has been focusing efforts on adopting innovations. Dr. Norman Sharpless, the agency's new commissioner, has pushed the decision to call on new companies to test the current framework of their Digital Health Software Precertification Program.<\/p>

The objective of the program is to facilitate the regulation of Digital Health products prone to frequent updates. In this way, new companies and startups<\/em> can ensure that their efforts are 100% certified by the United States Government and thus be exempt from fines and regulatory notices.<\/p>\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\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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The Center for Devices and Radiological Health of the FDA<\/strong> (responsible for giving continuity to the program) has only one priority: patients. Providing access to high-quality, safe and effective innovations, from mobile applications, sensors for measuring physical activity, among others, is paramount. In the same way, the use of algorithms embedded in digital platforms that favor the clinical decision making that doctors make daily, is of vital importance.<\/p>

The conscious effort of the United States government to improve the user experience through Digital Health doesn\u2019t stop at the certification of new companies. They have also focused on alerting patients and health service providers, by warning them about the dangers of devices and software for the control of diabetes and other chronic diseases that have not been evaluated by the agency.<\/p>\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

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\u201cWe must ensure that we can continue to provide a first standard in terms of safety and effectiveness. We believe that the agency's guidance will help advance the development of these innovative products,\"<\/em> said Dr. Scott Gottlieb, former FDA commissioner.<\/p>\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\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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The FDA's total product life cycle approach allows you to evaluate and monitor a software product from its pre-marketing development to post-sale performance. This brings a specific benefit, which is a personalized and pragmatic regulatory oversight that evaluates organizations of all sizes, to establish the confidence that they have a culture of quality and excellence that results in safe products for the patient.<\/p>

It\u2019s very important to know, publicize and verify that all devices and technologies adopted for health care comply with quality and protection standards in favor of users.<\/p>\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\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tBIBLIOGRAPHY<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t

MOBIHEALTH NEWS<\/strong><\/p>

https:\/\/www.mobihealthnews.com\/news\/north-america\/fda-sought-new-precert-participants-cleared-new-digital-health-products-and-more<\/a><\/p>

\u00a0<\/strong>FDA<\/strong><\/p>

https:\/\/www.fda.gov\/medical-devices\/digital-health\/digital-health-software-precertification-pre-cert-program<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\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<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

Gracias al Programa de Precertificaci\u00f3n que se encarga de regular los alimentos y medicamentos mediante un software dentro del gobierno estadounidense, diversas empresas obtuvieron el registro de dispositivos m\u00e9dicos, algoritmos basados en inteligencia artificial y herramientas de diagn\u00f3stico. La Agencia de Administraci\u00f3n de Medicamentos y Alimentos (FDA por sus siglas en ingl\u00e9s, Food and Drug Administration) ha estado abocando esfuerzos en la adopci\u00f3n de innovaciones. El Dr. Norman Sharpless, nuevo comisionado de la agencia, ha impulsado la decisi\u00f3n sobre hacer un llamado a nuevas empresas para que prueben el marco actual de su Programa de Precertificaci\u00f3n de Software de Salud Digital. El objetivo del programa es facilitar la regulaci\u00f3n de los productos de Salud Digital propensos a actualizaciones frecuentes. De esta manera, las nuevas compa\u00f1\u00edas y startups pueden asegurarse de que sus esfuerzos est\u00e1n 100% certificados por el gobierno de Estados Unidos y as\u00ed estar exentos a multas y avisos regulatorios. El Centro de Dispositivos y Salud Radiol\u00f3gica de la FDA (encargado de darle continuidad al programa) tiene una sola prioridad: los pacientes. Brindar acceso a innovaciones de alta calidad, segura y efectiva, desde aplicaciones m\u00f3viles, sensores para le medici\u00f3n de actividad f\u00edsica, entre otros, es primordial. Del mismo modo, el uso de algoritmos embebidos en plataformas digitales que favorezcan la toma de decisiones cl\u00ednicas que los m\u00e9dicos toman a diario, es de vital importancia. El esfuerzo consciente del gobierno de Estados Unidos por mejorar la experiencia del usuario a trav\u00e9s de la Salud Digital no se detiene en la certificaci\u00f3n de nuevas empresas. Tambi\u00e9n han puesto el foco en alertar a pacientes y proveedores de servicios de salud, al advertirles sobre los peligros de los dispositivos y software para el control de la diabetes y otras enfermedades cr\u00f3nicas que no han sido evaluados por la agencia. \u201cDebemos asegurarnos de que podemos continuar brindando un est\u00e1ndar de primera en t\u00e9rminos de seguridad y efectividad. Creemos que la orientaci\u00f3n de la agencia ayudar\u00e1 a avanzar en el desarrollo de estos productos innovadores”, declar\u00f3 el Dr. Scott Gottlieb, antiguo comisionado de la FDA. El planteamiento del ciclo de vida total del producto de la FDA permite evaluar y monitorear un producto de software desde su desarrollo previo a la comercializaci\u00f3n hasta el desempe\u00f1o posterior a su venta. Esto trae un beneficio espec\u00edfico, el cual es una supervisi\u00f3n reguladora personalizada y pragm\u00e1tica que eval\u00fae a las organizaciones de todos los tama\u00f1os, para establecer la confianza de que tienen una cultura de calidad y excelencia que resulte en productos seguros para el paciente. Es muy importante conocer, dar a conocer y verificar que todos los dispositivos y tecnolog\u00edas que se adopten para el cuidado de la salud cumplan con normas de calidad y protecci\u00f3n en favor de los usuarios. BIBLIOGRAF\u00cdA MOBIHEALTH NEWS https:\/\/www.mobihealthnews.com\/news\/north-america\/fda-sought-new-precert-participants-cleared-new-digital-health-products-and-more  FDA https:\/\/www.fda.gov\/medical-devices\/digital-health\/digital-health-software-precertification-pre-cert-program<\/p>","protected":false},"author":1,"featured_media":5436,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[152,156,160],"tags":[145],"class_list":["post-5435","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-avance-de-la-ciencia","category-big-data","category-noticias","tag-noticias"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/5435","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/comments?post=5435"}],"version-history":[{"count":0,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/5435\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media\/5436"}],"wp:attachment":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media?parent=5435"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/categories?post=5435"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/tags?post=5435"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}