REPORT ON NON-DEVICE SOFTWARE FUNCTIONS: IMPACT TO HEALTH AND BEST PRACTICES – DECEMBER 2018
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
Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures
Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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 […]
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.
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
Announcement here: Meetings: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee.