Earlier this week, on January 8, 2024, the United States FDA announced a revised version of its guidance on medical device sterility:Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. This update revises the guidance to ...
Here are summaries of the latest FDA guidance and communications on medical devices:In January, the FDA updated the final guidance on Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. The FDA now considers vaporized hydrogen...
Related to obtaining more patient data to support its reviews, FDA also plans to issue draft guidance on theUse of Real-World Observational Patient Data to Support Decision Making for Medical Devices, including possibly the use of "big data" studies of electronic health records (EHRs) that can...
21 CFR Part 820 - Quality System Regulation for Medical Devices:该法规规定了医疗器械制造商必须遵循的质量体系要求,其中包括与生产环境有关的一些要求。 4.环境监控的指南: Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice:这是一份关于用无菌工...
(k)) Submission for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff, FDA recommends that package test methods include simulated distribution as well as simulated (and/or real-time) aging followed each by associated packaging testing, to validate package ...
The draft guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, is a “cornerstone of our strategic priority of creating a national evaluation system for medical devices,” the FDA wrote in an email. “That system would build on and leverage the ...
Here are summaries of the latest FDA guidance and communications on medical devices:In January, the FDA updated the final guidance on Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. The FDA now considers vaporized hydrogen...
关于建立和维护符合cgmp的质量体系的指南,请参见FDA的指南:Q8(R2)药物开发:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q8r2-pharmaceutical-development, Q9质量风险管理:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q9-quality-risk-management, Q10药物...
Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices (ELD) Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments ...
CHAPTER3 - DEVICES CHAPTER6 - VETERINARY MEDICINE 附3. REGULATORY PROCEDURESMANUAL 管理程序手册 CDERGUIDELINES CDER指导方针 1.Bulk Pharmaceutical Chemicals, 9/91 2.Preparation of IND Products, 3/91 3.Sterile Drug Products - Aseptic Processing, 6/87 ...