CDRH: /about-fda/cdrh-offices/cdrh-management-directory-organization. 6 See 21 CFR 312.30(b) and 812.35(a). Under applicable Federal regulations, investigators must engage with the Drug Enforcement Administration when amending protocols for research involving Schedule I substances under the Controlled ...
点击Compliance Program Manual(合规计划手册):FDA的合规计划是按以下计划领域组织的,包括Biologics (CBER)生物制品 (CBER)、Bioresearch Monitoring (BIMO)生物研究监测(BIMO)、Devices/Radiological Health (CDRH)器械/放射卫生(CDRH)、Drugs (CDER)药品(CDER)、Food and Cosmetics (CFSAN))食品和化妆品(CFSAN))与Ve...
点击Compliance Program Manual(合规计划手册):FDA的合规计划是按以下计划领域组织的,包括Biologics (CBER)生物制品 (CBER)、Bioresearch Monitoring (BIMO)生物研究监测(BIMO)、Devices/Radiological Health (CDRH)器械/放射卫生(CDRH)、Drugs (CDER)药品(CDER)、Food and Cosmetics (CFSAN...
“这项规则旨在确保患者和医疗服务提供者在全球范围内及时,持续地获得安全,有效和高质量的医疗设备,”FDA医疗设备和放射卫生中心(CDRH)主任Jeff Shuren表示,“通过将该规则的实施,FDA简化了医疗设备制造商必须采取的措施,以满足多个监管机构的要求。” 设备制造商和进口商将有两年时间,即至2026年2月2日,修改其质量体...
美国食品与药品监督管理局(FDA)发布了期待已久的Quality Management System Regulation (QMSR) Final Rule《质量管理体系法规》最终规则,目标是与国际标准化组织(ISO)广泛认可的标准协调一致。FDA表示,这项规则的制定,是其为促进设备监管一致性而采取的最新行动,预计每年将为行业节省数亿美元。
If you have any questions, please contact the Director of the Division of Radiological Health, or the branch chief of your respective product area, as listed on the CDRH Management Directory, under the Office of In Vitro Diagnostics and Radiological Health, Division of Radiological Health. ...
In 2019, CDRH completed reorganization, consolidating and integrating product review, quality, surveillance and enforcement programs into a new, team-based approach. Currently, as the Director of the Office of Health Technology 1: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, I am resp...
In light of this, we would like to offer some ideas regarding how to measure – quantify – how good your “quality” is in tangible and practical terms.We contend that such metrics are useful in order for company management to make sound decisions regarding whether and/or where the quality...