RESUMO
Policy Points Current medical device regulatory frameworks date back half a century and are ill suited for the next generation of medical devices that involve a significant software component. Existing Food and Drug Administration efforts are insufficient because of a lack of statutory authority, whereas international examples offer lessons for improving and harmonizing domestic medical device regulatory policy. A voluntary alternative pathway built upon two-stage review with individual component review followed by holistic review for integrated devices would provide regulators with new tools to address a changing medical device marketplace.
Assuntos
Aprovação de Equipamentos , United States Food and Drug Administration , Estados Unidos , Humanos , Aprovação de Equipamentos/legislação & jurisprudência , Regulamentação Governamental , Legislação de Dispositivos Médicos , Equipamentos e ProvisõesRESUMO
The procedures of prenatal and preimplantation diagnostics are discussed critically again and again in our community. In addition to the permanently controversial issues of embryo protection and abortion, considerations that discrimination on the basis of disability could occur with problematic consequences also for already born people with disabilities and their relatives now play a central role.
Assuntos
Teste Pré-Natal não Invasivo/ética , Feminino , Alemanha , Humanos , Legislação de Dispositivos Médicos , Programas Nacionais de Saúde/economia , Programas Nacionais de Saúde/legislação & jurisprudência , Teste Pré-Natal não Invasivo/economia , Teste Pré-Natal não Invasivo/legislação & jurisprudência , GravidezRESUMO
INTRODUCTION: The 'one biomarker/one drug' scenario is unsustainable because cancer is a complex disorder that involves a number of molecular defects. In the past decade, major technological advances have lowered the overall cost and increased the efficiency of next-generation sequencing (NGS). AREAS COVERED: We review recent regulations on NGS and complementary diagnostics in Japan, mainly focusing on high-quality studies that utilized these new diagnostic modalities and were published within the last 5 years. We highlight significant changes in regulation, and explain the direction of efforts to translate the results of NGS and complementary diagnostics into clinical practice. EXPERT OPINION: NGS holds a number of advantages over conventional companion and complementary diagnostics that enable simultaneous analyzes of multiple cancer genes to detect actionable mutations. Parallel technological developments and regulatory changes have led to the rapid adoption of NGS into clinical practice. NGS-based genomic data have been leveraged to better understand the characteristics of a disease that affects its patient's response to a given therapy. As NGS-based tests become more widespread, however, Japanese authorities will face significant challenges particularly with respect to the complexity of genomic data, which will have to be managed if NGS is to benefit patients.
Assuntos
Sequenciamento de Nucleotídeos em Larga Escala/tendências , Legislação de Dispositivos Médicos , Técnicas de Diagnóstico Molecular/tendências , Neoplasias/tratamento farmacológico , Medicina de Precisão/métodos , Antígeno B7-H1/antagonistas & inibidores , Antígeno B7-H1/genética , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/genética , Análise Mutacional de DNA/economia , Análise Mutacional de DNA/métodos , Análise Mutacional de DNA/tendências , Bases de Dados de Ácidos Nucleicos , Aprovação de Equipamentos/legislação & jurisprudência , Triagem e Testes Direto ao Consumidor/economia , Triagem e Testes Direto ao Consumidor/legislação & jurisprudência , Resistência Microbiana a Medicamentos/genética , Equipamentos e Provisões/classificação , Doenças Genéticas Inatas/tratamento farmacológico , Doenças Genéticas Inatas/genética , Órgãos Governamentais/organização & administração , Necessidades e Demandas de Serviços de Saúde , Sequenciamento de Nucleotídeos em Larga Escala/economia , Sequenciamento de Nucleotídeos em Larga Escala/instrumentação , Sequenciamento de Nucleotídeos em Larga Escala/métodos , Humanos , Inibidores de Checkpoint Imunológico/farmacologia , Inibidores de Checkpoint Imunológico/uso terapêutico , Japão , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/genética , Técnicas de Diagnóstico Molecular/economia , Técnicas de Diagnóstico Molecular/métodos , Terapia de Alvo Molecular , Mutação , Programas Nacionais de Saúde , Proteínas de Neoplasias/antagonistas & inibidores , Proteínas de Neoplasias/genética , Neoplasias/genéticaAssuntos
Preparações Farmacêuticas , Controle de Medicamentos e Entorpecentes , Planejamento em Saúde , Assistência de Saúde Universal , Equipamentos e Provisões , Legislação de Dispositivos Médicos , Sangue , Vacinas , Kit de Reagentes para Diagnóstico , Refrigeração , Terapia Biológica , AntivenenosRESUMO
As is the case in other sectors, innovative digital products have started to enter the health market, too. If digital products like apps are considered medical devices, startups are often confronted with regulatory procedures that they deem to be slow and with which they are not familiar. This applies to both the certification procedures and the requirements and procedures for reimbursement, where problems could occur. The aim of this article is to better understand the startups' experience in navigating through these procedures, the hurdles they encounter, and their need for support. Therefore, the digital association Bitkom e.â¯V. and the Federal Institute for Drugs and Medical Devices (BfArM) conducted a web-based survey on five themes with a total of 23 questions. These questions focused inter alia on the composition of the team, product planning, familiarity with regulatory requirements, experience with institutions and different sources of information, the assessment of challenges in the process, and the resulting need for support.The analysis on the basis of 18 complete replies has shown that startups work on products with documentation and communications functions, but also integrate diagnostic and therapeutic features. The latter are characteristics of medical devices. Startups consider themselves to be relatively familiar with regulatory requirements regarding medical devices. The largest hurdles are associated with reimbursement: long and costly processes until the startups' products could be reimbursed.Both with regard to reimbursement and certification, startups see a need for low-threshold, cost-efficient advisory services and a simplification and acceleration of existing procedures with regard to medical devices.
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Certificação/organização & administração , Comércio/organização & administração , Legislação de Dispositivos Médicos/organização & administração , Telemedicina/organização & administração , Certificação/legislação & jurisprudência , Comércio/legislação & jurisprudência , Aprovação de Equipamentos/legislação & jurisprudência , Alemanha , Setor de Assistência à Saúde/organização & administração , Humanos , Programas Nacionais de Saúde/legislação & jurisprudência , Programas Nacionais de Saúde/organização & administração , Garantia da Qualidade dos Cuidados de Saúde/legislação & jurisprudência , Garantia da Qualidade dos Cuidados de Saúde/organização & administração , Mecanismo de Reembolso/organização & administração , Software , Telemedicina/legislação & jurisprudênciaRESUMO
Smartphones and tablets with their nearly unlimited number of different applications have become an integral part of everyday life. Thus, mobile devices and applications have also found their way into the healthcare sector.For developers, manufacturers, or users as well, it is often difficult to decide whether a mobile health application is a medical device.In this context, it is extremely important for manufacturers to decide at an early stage of the development whether the product is to be introduced into the market as a medical device and is therefore subject to the legislation on medical devices.This article first presents the regulatory framework and subsequently introduces the reader to the Federal Institute for Drugs and Medical Devices' (BfArM) view of the criteria for differentiating between apps as non-medical products and apps as medical apps as well as the classification thereof. Various examples are presented to demonstrate how these criteria are applied practically and options that support developers and manufacturers in their decision making are shown. The article concludes with a reference to current developments and offers a perspective on the new European medical device regulations MDR/IVDR (Medical Device Regulation/In-Vitro Diagnostic Regulation) as well as on future challenges regarding medical apps.
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Aprovação de Equipamentos/legislação & jurisprudência , Legislação de Dispositivos Médicos , Aplicativos Móveis/legislação & jurisprudência , Software/legislação & jurisprudência , Aprovação de Equipamentos/normas , Alemanha , Humanos , Aplicativos Móveis/normas , Programas Nacionais de Saúde/legislação & jurisprudência , Software/classificação , Software/normas , Design de SoftwareAssuntos
Técnicas Eletrofisiológicas Cardíacas/instrumentação , Utilização de Equipamentos e Suprimentos/legislação & jurisprudência , Equipamentos e Provisões/normas , Legislação de Dispositivos Médicos/organização & administração , Europa (Continente) , Humanos , Vigilância de Produtos ComercializadosRESUMO
Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.
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Legislação de Dispositivos Médicos , Cuba , Política de Saúde , Humanos , Programas Nacionais de SaúdeRESUMO
Medical devices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion.
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Equipamentos e Provisões/normas , Avaliação da Tecnologia Biomédica/normas , Biomarcadores , Análise Custo-Benefício , Procedimentos Clínicos , Árvores de Decisões , Equipamentos e Provisões/efeitos adversos , Equipamentos e Provisões/economia , França , Humanos , Reembolso de Seguro de Saúde , Invenções , Legislação de Dispositivos Médicos , Programas Nacionais de Saúde , Avaliação da Tecnologia Biomédica/organização & administraçãoRESUMO
The statute and regulations administered by the Food and Drug Administration ("FDA") do not explicitly prohibit the promotion of drugs and medical devices for unapproved uses, yet the government has collected billions of dollars in penalties for such "off-label" promotion. The statutory interpretations and regulatory provisions relied on by the government to take enforcement action against off-label promotion are the incidental by-products of initiatives undertaken by FDA through administrative action and litigation early in its implementation of the Federal Food, Drug, and Cosmetic Act. The actions were designed to obtain FDA authority over therapeutic claims made in advertising, even though Congress had assigned authority over advertising to the Federal Trade Commission, and to establish a prescription-only drug system, even though FDA lacked statutory authority for such a system. The principal purpose of both efforts was to prevent inappropriate self-medication. This article describes the history of those strategies, including expansion of the definition of the term "labeling" to encompass matter that was initially regarded as advertising; creation of the rule that the labeling of drugs must have adequate directions for all "intended" uses; and construction of the prescription-only drug system in a manner that allowed FDA to use the statutory requirement for labeling to have "adequate directions for use" to prohibit the off-label promotion of prescription drugs.
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Legislação de Medicamentos , Legislação de Dispositivos Médicos , Uso Off-Label/legislação & jurisprudência , United States Food and Drug Administration/legislação & jurisprudência , Publicidade/legislação & jurisprudência , Rotulagem de Medicamentos/legislação & jurisprudência , Promoção da Saúde/legislação & jurisprudência , Preparações de Plantas , Medicamentos sob Prescrição , Charlatanismo/legislação & jurisprudência , Estados Unidos , United States Federal Trade Commission/legislação & jurisprudênciaRESUMO
The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcutaneous electrical nerve stimulator to treat headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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Aprovação de Equipamentos/legislação & jurisprudência , Segurança de Equipamentos/classificação , Estimulação Elétrica Nervosa Transcutânea/classificação , Estimulação Elétrica Nervosa Transcutânea/instrumentação , Cefaleia/terapia , Humanos , Legislação de Dispositivos Médicos , Estados Unidos , United States Food and Drug Administration/legislação & jurisprudênciaRESUMO
Consumption of alkaline reduced water produced by domestic electrolysis devices was approved in Japan in 1965 by the Minister of Health, Work and Wellbeing, for the treatment of gastrointestinal disorders. Today, these devices are also freely available in France. The commercial information provided with the devices recommends the consumption of 1 to 1.5 liters per day, not only for gastrointestinal disorders but also for numerous other illnesses such as diabetes, cancer and inflammation. Academic research on this subject has been undergoing in Japan since 1990, and has established that the active ingredient is dissolved dihydrogen, which eliminates the free radical HO· in vivo. It has also been shown that electrode degradation during use of the devices releases highly reactive platinum nanoparticles, the toxicity of which is unknown. The authors of this report recommend alerting the French health authorities to the uncontrolled availability of these devices that generate drug substances and should therefore be subject to regulatory requirements.