| [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
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| [Mh] Termos MeSH secundário: |
Equipamentos e Provisões/efeitos adversos
Seres Humanos
Implante de Prótese
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| [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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