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[PMID]:29203752
[Au] Autor:Gruber-Bzura BM
[Ad] Endereço:Zaklad Biochemii I Biofarmaceutykow; Narodowy Instytut Lekow, Warszawa Polska.
[Ti] Título:[Cytotoxicity in vitro as the principal parameter for evaluation of biocompatibility of medical devices].
[So] Source:Wiad Lek;70(5):977-981, 2017.
[Is] ISSN:0043-5147
[Cp] País de publicação:Poland
[La] Idioma:pol
[Ab] Resumo:According to the Polish Ministry of Health decree, the medical devices and all raw materials used for their manufacturing are in force to be compatible with biological tissues, cells and body fluids regarding its clinical use. It is defined as biocompatibility. The scope of the methods proposed in the norm PN-EN ISO 10993-1 makes possible to get full preclinical characteristics of the medical device and allows to form the opinion about safety of it to the patients after its marketing. The test directed as the principal to make, independently on characteristics, kind, contact duration and clinical use of the device is cytotoxicity in vitro. This test defines the impact of the device on the cells through microscopic evaluation or through activities of the enzymes specific for living cells. Toxicity of the material to the cells may be reflected in: change of single cells or whole cell culture morphology, change of cellular metabolic activity, DNA damage or disadvantage of cell proliferation. Biocompatibility of the medical devices is one of the main elements considered in a risk management process at the stage of designing and manufacturing as well of the raw materials as the final product and the critical point in this matter is sterilization.
[Mh] Termos MeSH primário: Materiais Biocompatíveis/normas
Equipamentos e Provisões/normas
Teste de Materiais/normas
Testes de Toxicidade/normas
[Mh] Termos MeSH secundário: Seres Humanos
Legislação de Dispositivos Médicos
Polônia
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Biocompatible Materials)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171206
[St] Status:MEDLINE


  2 / 151 MEDLINE  
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[PMID]:28687634
[Au] Autor:Genzen JR; Mohlman JS; Lynch JL; Squires MW; Weiss RL
[Ad] Endereço:Department of Pathology, University of Utah, Salt Lake City, UT; jonathan.genzen@path.utah.edu.
[Ti] Título:Laboratory-Developed Tests: A Legislative and Regulatory Review.
[So] Source:Clin Chem;63(10):1575-1584, 2017 Oct.
[Is] ISSN:1530-8561
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Twenty-five years ago, the Food and Drug Administration (FDA) asserted in a draft document that "home brew" tests-now commonly referred to as laboratory-developed tests (LDTs)-are subject to the same regulatory oversight as other in vitro diagnostics (IVDs) . In 2010, the FDA began work on developing a proposed framework for future LDT oversight. Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation. While the proposed guidance has not been implemented, many questions regarding LDT oversight remain unresolved. CONTENT: This review provides an overview of federal statutes and regulations related to IVDs and clinical laboratory operations, with a focus on those potentially applicable to LDTs and proposed regulatory efforts. Sources reviewed include the Code of Federal Regulations, the Federal Register, congressional hearings, guidance and policy documents, position statements, published literature, and websites. SUMMARY: Federal statutes regarding IVDs were passed without substantive evidence of congressional consideration toward the concept of LDTs. The FDA has clear oversight authority over IVD reagents introduced into interstate commerce. A 16-year delay in publicly asserting FDA authority over LDTs, the pursuit of a draft guidance approach toward oversight, and establishment of regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) applicable to LDTs contributed to community uncertainty toward LDT oversight. Future regulatory and/or legislative efforts may be required to resolve this uncertainty.
[Mh] Termos MeSH primário: Serviços de Laboratório Clínico/legislação & jurisprudência
Técnicas de Laboratório Clínico
Laboratórios/legislação & jurisprudência
Legislação de Dispositivos Médicos
[Mh] Termos MeSH secundário: Testes Genéticos/legislação & jurisprudência
Seres Humanos
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171013
[Lr] Data última revisão:
171013
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170709
[St] Status:MEDLINE
[do] DOI:10.1373/clinchem.2017.275164


  3 / 151 MEDLINE  
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Texto completo SciELO Chile
[PMID]:28548196
[Au] Autor:López S G; Valdés S G; Roessler B E; Valdivieso D V
[Ad] Endereço:Comité de Estudio y Redacción, Academia Chilena de Medicina, Santiago, Chile.
[Ti] Título:[Declaration of the Chilean Academy of Medicine of Law 20.850 “On clinical trials of pharmaceutical products and medical devices” and of the bylaw that will regulate its application].
[Ti] Título:Declaración de la Academia Chilena de Medicina sobre el Título V de la Ley 20.850 (Ley Ricarte Soto) y su proyecto de reglamento “De los ensayos clínicos de productos farmacéuticos y elementos de uso médico”..
[So] Source:Rev Med Chil;145(3):380-385, 2017 Mar.
[Is] ISSN:0717-6163
[Cp] País de publicação:Chile
[La] Idioma:spa
[Ab] Resumo:In Chile, high cost treatments required by selected medical conditions are financed by the State, according to Law 20.850. A bylaw under discussion by the Senate regulates clinical trials, posing complex issues that will endanger local interest in front-line research: 1. The exclusive and mandatory control bestowed to the Institute of Public Health during all stages of the trials and also the surveillance of institutions performing clinical trials, overriding their Clinical Research Review Boards; 2.The 10 year period during which any adverse event is assumed to have been caused by the medication or devise evaluated by the trial, unless the contrary is proven in a judicial process; 3. Individuals submitted to the trials are entitled to free post trial access to the treatment received during the study, financed by the trial supporting entities and as long as the drug or devise is considered to be useful. While agreeing with the need to have a National Registry of Clinical Trials, we predict that the mentioned critical issues in the bylaw will lead to difficulties and unnecessary judicial processes, thus limiting clinicians’ interest in performing research. We propose to modify the bylaw, excluding responsibilities on events associated with the natural evolution of the medical condition, with patients’ ageing or with comorbidities and clinical events considered unpredictable when the protocol was accepted. We recommend that the free post trial access should be a joint decision involving the patient and the attending physician, taking in consideration that the volunteer has been exposed to risks and burdens, or when discontinuation of treatment entails a vital risk until the treatment under study has been approved and becomes available in the national market.
[Mh] Termos MeSH primário: Academias e Institutos/legislação & jurisprudência
Ensaios Clínicos como Assunto/legislação & jurisprudência
Legislação de Medicamentos
Legislação de Dispositivos Médicos
[Mh] Termos MeSH secundário: Chile
Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170808
[Lr] Data última revisão:
170808
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170527
[St] Status:MEDLINE


  4 / 151 MEDLINE  
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[PMID]:28496147
[Au] Autor:Hunter NL; Sherman RE
[Ad] Endereço:Office of Medical Products and Tobacco, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
[Ti] Título:Combination products: modernizing the regulatory paradigm.
[So] Source:Nat Rev Drug Discov;16(8):513-514, 2017 Aug.
[Is] ISSN:1474-1784
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:New opportunities to develop innovative - and often complex - products that combine drugs, devices and/or biological components are rapidly emerging, raising questions about how such products should be regulated. Here, we discuss the ongoing efforts of the FDA to develop a modern, transparent, flexible and consistent science-based regulatory approach for combination products.
[Mh] Termos MeSH primário: Aprovação de Equipamentos/legislação & jurisprudência
Aprovação de Drogas/legislação & jurisprudência
Controle de Medicamentos e Entorpecentes
Legislação de Dispositivos Médicos
[Mh] Termos MeSH secundário: Desenho de Drogas
Desenho de Equipamento
Seres Humanos
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170804
[Lr] Data última revisão:
170804
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170513
[St] Status:MEDLINE
[do] DOI:10.1038/nrd.2017.66


  5 / 151 MEDLINE  
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[PMID]:28381721
[Au] Autor:Hojo T
[Ad] Endereço:Pharmaceuticals and Medical Devices Agency.
[Ti] Título:Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).
[So] Source:Yakugaku Zasshi;137(4):439-442, 2017.
[Is] ISSN:1347-5231
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo:Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.
[Mh] Termos MeSH primário: Desenho de Drogas
Controle de Medicamentos e Entorpecentes
Desenho de Equipamento
Segurança de Equipamentos
Legislação de Dispositivos Médicos
Segurança
Ciência
[Mh] Termos MeSH secundário: Bases de Dados como Assunto
Órgãos Governamentais
Sistemas de Informação em Saúde
Controle de Qualidade
Medição de Risco
Gestão de Riscos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1705
[Cu] Atualização por classe:171017
[Lr] Data última revisão:
171017
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170407
[St] Status:MEDLINE
[do] DOI:10.1248/yakushi.16-00244-4


  6 / 151 MEDLINE  
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[PMID]:28381720
[Au] Autor:Niimi S
[Ad] Endereço:Division of Medical Devices, National Institute of Health Sciences.
[Ti] Título:Practice of Regulatory Science (Development of Medical Devices).
[So] Source:Yakugaku Zasshi;137(4):431-437, 2017.
[Is] ISSN:1347-5231
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo:Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made. In the approval application process, medical devices are divided into new, improved, and generic types. Reviewers judge the validity of intended use, indications, operation procedures, and precautions, and in addition evaluate the balance between risk and benefit in terms of efficacy and safety. Other characteristics of medical devices are the need for the user to attain proficiency in usage techniques to ensure efficacy and safety, and the existence of a variety of medical devices for which assessment strategies differ, including differences in impact on the body in cases in which a physical burden to the body or failure of a medical device develops. Regulatory science of medical devices involves prediction, judgment, and evaluation of efficacy, safety, and quality, from which data result which can become indices in the development stages from design to application for approval. A reduction in the number of animals used for testing, improvement in efficiency, reduction of the necessity for clinical trials, etc. are expected through rational setting of evaluation items.
[Mh] Termos MeSH primário: Desenho de Equipamento
Legislação de Dispositivos Médicos
Medição de Risco
Gestão de Riscos
Ciência
[Mh] Termos MeSH secundário: Experimentação Animal/estatística & dados numéricos
Animais
Ensaios Clínicos como Assunto/estatística & dados numéricos
Aprovação de Equipamentos
Segurança de Equipamentos
Equipamentos e Provisões/classificação
Seres Humanos
Equipamentos Cirúrgicos
Instrumentos Cirúrgicos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1705
[Cu] Atualização por classe:171017
[Lr] Data última revisão:
171017
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170407
[St] Status:MEDLINE
[do] DOI:10.1248/yakushi.16-00244-3


  7 / 151 MEDLINE  
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[PMID]:28128008
[Au] Autor:Neyt M; Baeyens H; Pouppez C; Slegers P; Hulstaert F; Stordeur S; Vinck I
[Ad] Endereço:a Belgian Health Care Knowledge Centre (KCE) , Brussels , Belgium.
[Ti] Título:Introduction of high-risk medical devices: national measures that can be taken under the current European legislation to put the patient interest central.
[So] Source:Expert Rev Med Devices;14(3):181-188, 2017 Mar.
[Is] ISSN:1745-2422
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: High-risk medical devices may not always provide a therapeutic added value to patients. In Europe, no proof of efficacy is required to receive a CE label, making it difficult for policymakers to decide on reimbursement of (often expensive) high-risk medical devices. We explore, within the framework of the European legislation, the possibilities at a national level for a guided introduction of such devices. Areas covered: HTA and legal experts worked in close collaboration with medical specialists and government representatives making a legal analysis of what is possible under the (revised) European and national legislation. Expert commentary: At national level, measures for a better evidence-based introduction can be taken that are not in contradiction with the European regulation. From a legal point of view, all restrictive measures must be justified, necessary and proportional. Several measures are possible, a.o. making use of reference centres, applying the IDEAL framework or the 6-step plan set up by the Dutch Order of Medical Specialists. In conclusion, within the framework of the (revised) European legislation, measures at national level can be taken to temporarily restrict and follow up the use of high-risk medical devices with a greater focus on the therapeutic added value for the patients.
[Mh] Termos MeSH primário: Equipamentos e Provisões
Legislação de Dispositivos Médicos
[Mh] Termos MeSH secundário: Europa (Continente)
Seres Humanos
Fatores de Risco
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170317
[Lr] Data última revisão:
170317
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170128
[St] Status:MEDLINE
[do] DOI:10.1080/17434440.2017.1288095


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[PMID]:28118463
[Au] Autor:Bonafide CP; Jamison DT; Foglia EE
[Ad] Endereço:Division of General Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania2Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.
[Ti] Título:The Emerging Market of Smartphone-Integrated Infant Physiologic Monitors.
[So] Source:JAMA;317(4):353-354, 2017 01 24.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Publicidade como Assunto
Aplicativos Móveis/tendências
Monitorização Fisiológica/tendências
Smartphone/tendências
[Mh] Termos MeSH secundário: Publicidade como Assunto/legislação & jurisprudência
Reações Falso-Positivas
Seres Humanos
Lactente
Legislação de Dispositivos Médicos
Aplicativos Móveis/economia
Aplicativos Móveis/legislação & jurisprudência
Monitorização Fisiológica/economia
Monitorização Fisiológica/instrumentação
Smartphone/legislação & jurisprudência
Morte Súbita do Lactente/prevenção & controle
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL
[Em] Mês de entrada:1702
[Cu] Atualização por classe:170220
[Lr] Data última revisão:
170220
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170125
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2016.19137


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[PMID]:28092200
[Au] Autor:Holzer R; Goble J; Hijazi Z
[Ad] Endereço:a Division of Cardiology , Sidra Medical and Research Center , Doha , Qatar.
[Ti] Título:The challenges surrounding preclinical testing in transcatheter device development and the implications on the clinic.
[So] Source:Expert Rev Med Devices;14(2):87-92, 2017 Feb.
[Is] ISSN:1745-2422
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: Transcatheter devices have contributed significantly to the advances achieved in treating many cardiovascular conditions over the last few decades. Sophisticated and detailed preclinical testing is not only a regulatory requirement to support an investigational device exemption (IDE) application, but more crucially its success and accuracy is needed to safeguard patients during the subsequent clinical testing stages. Areas covered: This article covers the regulatory background as well as specific considerations related to pre-clinical testing of transcatheter devices. Expert commentary: The lifecycle of a device is complex, but the period of commercialization may be short with little time for manufacturers to recuperate the costs associated with device development and (pre) clinical testing. Regulatory bodies such as the FDA require comprehensive data on pre-clinical testing prior to considering approval of an investigational device exemption to start trials in humans, which should include some data on safety and efficacy of a device. Preclinical testing needs to evaluate a variety of factors, such biocompatibility, material performance, durability, toxicology, particulation, protection against user error and device malfunction, potential hazards, and many more.
[Mh] Termos MeSH primário: Cateterismo/instrumentação
Aprovação de Equipamentos
[Mh] Termos MeSH secundário: Animais
Seres Humanos
Legislação de Dispositivos Médicos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1702
[Cu] Atualização por classe:170227
[Lr] Data última revisão:
170227
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170117
[St] Status:MEDLINE
[do] DOI:10.1080/17434440.2017.1282313


  10 / 151 MEDLINE  
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[PMID]:28080154
[Au] Autor:Reeve L; Baldrick P
[Ad] Endereço:a Non-Clinical Strategy, Global Regulatory Affairs Strategy , Covance Laboratories Ltd., Harrogate , North Yorkshire , UK.
[Ti] Título:Biocompatibility assessments for medical devices - evolving regulatory considerations.
[So] Source:Expert Rev Med Devices;14(2):161-167, 2017 Feb.
[Is] ISSN:1745-2422
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: Biocompatibility assessment provides key data supporting medical device development and marketing. Although regional and international guidance is available, differences in proposed biocompatibility assessments or test methods lead to confusion and inefficiencies in generating the package of supporting nonclinical data. Areas covered: Modifications to available guidance for biological safety testing of medical devices, as described by the International Organisation for Standardisation (ISO) and the US Food and Drug Administration (FDA), have, over time, sometimes increased and sometimes decreased the level of harmonisation in testing requirements. These requirements continue to evolve, as shown by refinements and supplements to existing ISO 10,993 standards, new ISO standards under development and new finalised guidance from the FDA - which shows a shift away from routine testing-based approaches and much greater emphasis on characterisation, with use of existing literature or demonstration of equivalence to established comparator products, where possible. Expert commentary: This article examines the impact of recent changes in guidance for biocompatibility assessment of new medical devices and shows that, although a high level of consistency now occurs in ISO and FDA requirements, there are still areas where a 'standard approach' is not possible, allowing hurdles for global development of medical devices to persist.
[Mh] Termos MeSH primário: Equipamentos e Provisões
Teste de Materiais/métodos
Legislação de Dispositivos Médicos
[Mh] Termos MeSH secundário: Equipamentos e Provisões/efeitos adversos
Seres Humanos
Implante de Prótese
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1702
[Cu] Atualização por classe:170227
[Lr] Data última revisão:
170227
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170113
[St] Status:MEDLINE
[do] DOI:10.1080/17434440.2017.1280392



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