Manufacturing Site Change Supplements: Content and Submission; Guidance for Industry and Food and Drug Administration Staff; Availabilityhttps://www.federalregister.gov/documents/2018/12/17/2018-27237/manufacturing-site-change-supplements-content-and-submission-guidance-for-industry-and-food-and-drug
New ANVISA public consultations related to quality and safety of health services. Novas consultas públicas da ANVISA relacionadas à qualidade e segurança de serviços em saúde.Consulta Pública nº 573 de 10/12/2018 – Proposta de Resolução de Diretoria Colegiada que dispõe sobre os requisitos sanitários para o funcionamento de serviços de radiologia diagnóstica ou intervencionista, e dá outras providências. Consulta Pública nº 574 de 10/12/2018 […]
Final rule will be at this link: FDA Issues Final Rule on Medical Device Classification Procedures A regra final será publicada neste link: FDA Issues Final Rule on Medical Device Classification Procedures
Some words from the US FDA about the duodenoscope problem, based on the post-market data : Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data Algumas palavras do US FDAsobre o problema dos duodenoscópios baseados nos dados […]
Another hot topic, together with Cybersecurity, is SaMD (Software as a Medical Device). Updated information from TGA here – Regulation of Software as a Medical Device. Outro tema quente, juntamente com cibersegurança, é o SaMD (Software as a Medical Device). Informações atualizadas da TGA aqui – Regulation of Software as a Medical Device.
Continuing with the duodenoscope topic: Olympus Medical pleads guilty to failing to file events notice: Justice Department. Continuando com o tema do duodenoscópios: Olympus Medical pleads guilty to failing to file events notice: Justice Department.
MHRA – Field safety notices – 03 to 07 December 2018. As a reminder, as part of Post Market Surveillance (PMS), manufacturers should track field safety notices to verify if similar devices had problems, and if the case, investigate if their device can also suffer from the same problem (and take action related to that). […]