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). […]
List of November 2018 510(k) clearances. With the recent suggestions by FDA management on future changes of the 510(k) process, keeping up-to-date with clearances (and potentially predicate devices) is even more important than ever. Lista de Novembro 2018 de 510 (k) clearances. Com as recentes sugestões da administração da FDA sobre futuras mudanças do processo 510(k), […]
This goes back to the ongoing duodenoscopes problems related to design and reprocessing… Isso remonta aos problemas relacionados ao design e reprocessamento de duodenoscópios…. The FDA Provides Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings: FDA Safety Communication
The EU Commission published some new templates for Field Safety Notices related to the current medical device directives and MEDDEV 2.12/1 rev.8. template links are below (they can also be found at: https://ec.europa.eu/growth/sectors/medical-devices/guidance_en). A Comissão da UE publicou alguns novos modelos para Avisos de Segurança de Campo relacionados às diretivas atuais de dispositivos médicos e ao MEDDEV 2.12 […]
Cybersecurity is and will be a hot topic in the medical devices field for a long time, as more and more devices are connected. Health Canada (together with the US FDA) are two of the regulatory bodies more concerned with this topic. Here is a link to a recent consultation on a guidance document: Health Canada […]