Month: December 2018

ANVISA – Consulta Pública nº 586 de 20/12/2018 – Diretrizes de Garantia da Qualidade para Validação, Monitoramento e Controle de Rotina dos Processos de Esterilização e Processos automatizados de Limpeza e Desinfecção em serviços de saúde

ANVISA – Public Consultation No. 586 of 12/20/2018 – Proposal for Normative Ruling on the Quality Assurance Guidelines for Validation, Monitoring and Routine Control of Sterilization Processes and Automated Processes for Cleaning and Disinfection in Health Services. ANVISA – Consulta Pública nº 586 de 20/12/2018 – Proposta de Instrução Normativa que dispõe sobre as Diretrizes […]

ANVISA – Consulta Pública nº 585 de 20/12/2018 – Boas Práticas para o Processamento de Produtos utilizados na assistência à saúde

ANVISA – Public Consultation No. 585 of 12/20/2018 – Proposal of Resolution of the Collegiate Board of Directors – RDC, which provides for the requirements of Good Practices for the Processing of Products used in health care, and provides other measures. ANVISA – Consulta Pública nº 585 de 20/12/2018 – Proposta de Resolução da Diretoria […]

CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation

Interesting findings – “results of the computer-simulated VICTRE trial are consistent with the comparative trial using human subjects and human image interpreters. While further research is needed to assess the generalizability of the findings, the work reported in this article provides evidence that state-of-the-art computational methods can lead to less burdensome regulatory evaluation approaches”. VICTRE: […]

Safety Alert – USFDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation

USFDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation Alerta de segurança – USFDA adverte sobre os riscos de segurança de colares de dentição, pulseiras para aliviar a dor na dentição ou para fornecer estimulação sensorial