{"id":54107,"date":"2021-11-26T11:04:51","date_gmt":"2021-11-26T16:04:51","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-issues-final-orders-to-reclassify-blood-lancet-devices-into-class-ii-and-class-iii-devices-orders-include-a-pma-requirement-for-class-iii-blood-lancets\/"},"modified":"2021-12-06T16:21:01","modified_gmt":"2021-12-06T21:21:01","slug":"fda-issues-final-orders-to-reclassify-blood-lancet-devices-into-class-ii-and-class-iii-devices-orders-include-a-pma-requirement-for-class-iii-blood-lancets","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/pt\/fda-issues-final-orders-to-reclassify-blood-lancet-devices-into-class-ii-and-class-iii-devices-orders-include-a-pma-requirement-for-class-iii-blood-lancets\/","title":{"rendered":"A FDA Emite Ordens Finais para Reclassificar Lancetas sangu\u00ednea como Dispositivos M\u00e9dicos de Classe II e Classe III; os Pedidos Incluem um Requisito PMA para Lancetas Classe III"},"content":{"rendered":"<p>Em 22 de novembro de 2021, a Administra\u00e7\u00e3o de Alimentos e Medicamentos (FDA) dos Estados Unidos emitiu 2 pedidos finais para lancetas de sangue.<\/p>\n<p>Um pedido reclassificou determinados dispositivos de lancetas de Sangue Classe I (com controles gerais), anteriormente isentos de notifica\u00e7\u00e3o pr\u00e9-venda, para Classe II (com controles especiais) e sujeitos a notifica\u00e7\u00e3o pr\u00e9-venda. O pedido tamb\u00e9m reclassificou determinados dispositivos da Classe I para a Classe III (tamb\u00e9m exigindo aprova\u00e7\u00e3o de pr\u00e9-comercializa\u00e7\u00e3o).<\/p>\n<p>O outro pedido final exige que os estabelecimentos comercializem dispositivos que foram reclassificados como Classe III para enviar uma solicita\u00e7\u00e3o de aprova\u00e7\u00e3o de pr\u00e9-venda (PMA) ou uma notifica\u00e7\u00e3o de rescis\u00e3o do Protocolo de Desenvolvimento de Produto (PDP) ao FDA.<\/p>\n<div class=\"callout-row text-center margin-bottom\">\n<h3>D\u00favidas sobre os regulamentos para dispositivos m\u00e9dicos?<\/h3>\n<p>Os especialistas em regulamenta\u00e7\u00e3o da Registrar Corp podem ajudar sua empresa a cumprir as regulamenta\u00e7\u00f5es da FDA dos EUA para dispositivos m\u00e9dicos. Para obter assist\u00eancia com os requisitos de conformidade, incluindo o preenchimento de 510 (k) ou PMA, entre em contato com Registrar Corpatrav\u00e9s do n\u00famero + 1-757-224-0177 ou converse com um Consultor Regulat\u00f3rio 24 horas por dia em nosso chat <a href=\"https:\/\/regstaging.wpengine.com\/livehelp\">regstaging.wpengine.com\/livehelp<\/a>.<\/p>\n<p class=\"btn-row\"><a class=\"btn btn-red-white\" href=\"https:\/\/regstaging.wpengine.com\/pt\/fda-medical-devices\/?lead_source=blog\">Obter assist\u00eancia<\/a><\/p>\n<\/div>\n<p>Continue lendo o Relat\u00f3rio para obter informa\u00e7\u00f5es mais detalhadas sobre as reclassifica\u00e7\u00f5es de dispositivos de lanceta de sangue, incluindo quando a FDA exige que voc\u00ea envie notifica\u00e7\u00f5es ou aprova\u00e7\u00f5es pr\u00e9-comercializa\u00e7\u00e3o para seus dispositivos.<\/p>\n<p><strong>Reclassifica\u00e7\u00f5es para Classe II<\/strong><\/p>\n<p>O <a href=\"https:\/\/www.federalregister.gov\/documents\/2021\/11\/22\/2021-25376\/medical-devices-general-and-plastic-surgery-devices-reclassification-of-blood-lancets\">pedido final da FDA sobre a reclassifica\u00e7\u00e3o de lancetas<\/a> de sangue segue uma ordem proposta, que a FDA publicou no Registro Federal em 3 de mar\u00e7o de 2016. A ordem final reclassifica efetivamente os seguintes dispositivos de lanceta de sangue da Classe I para a Classe II:<\/p>\n<ul>\n<li>Lancetas de sangue de uso unicamente com uma fun\u00e7\u00e3o abrangente de preven\u00e7\u00e3o de ferimento por materiais cortantes<\/li>\n<li>Lancetas de sangue de uso unicamente sem uma fun\u00e7\u00e3o abrangente de preven\u00e7\u00e3o de ferimento por materiais cortantes<\/li>\n<li>Lancetas de sangue multiuso para uso em um \u00fanico paciente<\/li>\n<\/ul>\n<p>A FDA emitiu a ordem proposta para reclassificar lancetas para um \u00fanico paciente em resposta \u00e0s recomenda\u00e7\u00f5es de um painel de classifica\u00e7\u00e3o de dispositivos que se reuniu em junho de 2013. A FDA est\u00e1 reclassificando os produtos acima para fornecer uma &#8220;garantia razo\u00e1vel de seguran\u00e7a e efic\u00e1cia.&#8221; controles especiais. Para esses dispositivos de Classe II, os controles especiais identificados no pedido final entrar\u00e3o em vigor em 22 de novembro de 2021.<\/p>\n<p>Se uma \u00fanica lanceta de sangue de paciente n\u00e3o foi colocada \u00e0 venda at\u00e9 22 de novembro de 2021 ou requer um novo 510 (k), o fabricante deve enviar uma notifica\u00e7\u00e3o pr\u00e9-comercializa\u00e7\u00e3o at\u00e9 22 de novembro de 2021. Se o produto foi colocado \u00e0 venda anteriormente, mas n\u00e3o foi ter a libera\u00e7\u00e3o 510 (k), o fabricante deve receber a libera\u00e7\u00e3o at\u00e9 22 de novembro de 2022. A FDA ir\u00e1 considerar tomar medidas coercitivas contra os fabricantes que comercializam tais produtos sem notifica\u00e7\u00e3o pr\u00e9via para comercializa\u00e7\u00e3o nas datas especificadas.<\/p>\n<p><strong>Reclassifica\u00e7\u00e3o na Classe III e Requisito PMA<\/strong><\/p>\n<p>O pedido final reclassifica lancetas de sangue multifuncionais para uso em v\u00e1rios pacientes da Classe I para a Classe III. A reclassifica\u00e7\u00e3o, em vigor a partir de 22 de novembro de 2021, torna esses produtos sujeitos \u00e0 aprova\u00e7\u00e3o pr\u00e9-comercializa\u00e7\u00e3o (PMA).<\/p>\n<p>A FDA est\u00e1 reclassificando esses produtos em resposta \u00e0 determina\u00e7\u00e3o do painel de reclassifica\u00e7\u00e3o de que n\u00e3o h\u00e1 dados suficientes para estabelecer controles especiais para lancetas de sangue multifuncionais para v\u00e1rios pacientes. O painel concluiu que essas lancetas podem representar um risco exagerado de doen\u00e7a ou les\u00e3o.<\/p>\n<p><strong>A FDA exige que os fabricantes de lancetas de sangue Classe III para v\u00e1rios pacientes apresentem um PMA em ou antes de 22 de maio de 2024.<\/strong> Se um estabelecimento n\u00e3o enviar um PMA para tal dispositivo, o FDA considerar\u00e1 o produto adulterado, a menos que o dispositivo tenha um aplicativo de isen\u00e7\u00e3o de dispositivo investigacional (IDE) aprovado.<\/p>\n<div class=\"callout-row text-center margin-bottom\">\n<h3>D\u00favidas sobre os regulamentos para dispositivos m\u00e9dicos?<\/h3>\n<p>Os especialistas em regulamenta\u00e7\u00e3o da Registrar Corp podem ajudar sua empresa a cumprir as regulamenta\u00e7\u00f5es da FDA dos EUA para dispositivos m\u00e9dicos. Para obter assist\u00eancia com os requisitos de conformidade, incluindo o preenchimento de 510 (k) ou PMA, entre em contato com Registrar Corpatrav\u00e9s do n\u00famero + 1-757-224-0177 ou converse com um Consultor Regulat\u00f3rio 24 horas por dia em nosso chat <a href=\"https:\/\/regstaging.wpengine.com\/livehelp\">regstaging.wpengine.com\/livehelp<\/a>.<\/p>\n<p class=\"btn-row\"><a class=\"btn btn-red-white\" href=\"https:\/\/regstaging.wpengine.com\/pt\/fda-medical-devices\/?lead_source=blog\">Obter assist\u00eancia<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Em 22 de novembro de 2021, a Administra\u00e7\u00e3o de Alimentos e Medicamentos (FDA) dos Estados Unidos emitiu 2 pedidos finais para lancetas de sangue. Um pedido reclassificou determinados dispositivos de lancetas de Sangue Classe I (com controles gerais), anteriormente isentos de notifica\u00e7\u00e3o pr\u00e9-venda, para Classe II (com controles especiais) e sujeitos a notifica\u00e7\u00e3o pr\u00e9-venda. O<\/p>\n","protected":false},"author":30,"featured_media":54076,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","om_disable_all_campaigns":false,"inline_featured_image":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[99],"tags":[],"class_list":{"0":"post-54107","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medical-devices-pt","8":"entry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.9 (Yoast SEO v25.5) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>A FDA Emite Ordens Finais para Reclassificar Lancetas sangu\u00ednea como Dispositivos M\u00e9dicos de Classe II e Classe III; os Pedidos Incluem um Requisito PMA para Lancetas Classe III - Registrar<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"A FDA Emite Ordens Finais para Reclassificar Lancetas sangu\u00ednea como Dispositivos M\u00e9dicos de Classe II e Classe III; os Pedidos Incluem um Requisito PMA para Lancetas Classe III\" \/>\n<meta property=\"og:description\" content=\"Em 22 de novembro de 2021, a Administra\u00e7\u00e3o de Alimentos e Medicamentos (FDA) dos Estados Unidos emitiu 2 pedidos finais para lancetas de sangue. 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