New FDA Guidance on Medical Devices: Enhanced Reporting Requirements for Adverse EventsGilmore, Melissa
New FDA draft guidance on medical device panel meetings generally confirms current practices, provides additional detailGerard J. Prud'hommeKristin M. Zielinski
英文原文 FDA Drafts Guidance on Inspections of Medical Device Establishments The US Food and Drug Administration (FDA) issued draft guidance on Thursday to implement uniform processes and standards for FDA inspections of domestic and foreign medical device establishments. FDA has updated processes and st...
植入心脏起搏器的这个也有Guidance。 对于有Device-Specific Guidance的产品,应该满足Guidance的相关要求,否则可能在受理的时候被Refuse To Accept - RTA。 (第6点的相关内容,也可以参考FDA 网页介绍 How to Study and Market Your Device) (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory...
While I may quibble with the details, this is far better than the lack of guidance they had prior to this. Forcing documentation of these issues should cause the security of medical devices to improve over time, and noting some common vulnerabilities to look out for doesn’t hurt. ...
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Guidance on Medical Device Tracking." This guidance is intended to provide guidelines to manufacturers and distributors about their responsibilities for medical device tracking under the Food, Drug and Cosmetic...
COVID-19 control measures on trials will vary depending on many factors, including the nature of the disease under study, the trial design and in what region(s) the study is being conducted, FDA has issued this Guidance to outline general considerations for sponso...
植入心脏起搏器的这个也有Guidance。 对于有Device-Specific Guidance的产品,应该满足Guidance的相关要求,否则可能在受理的时候被Refuse To Accept - RTA。 (第6点的相关内容,也可以参考FDA 网页介绍 How to Study and Market Your Device) (https://www.fda.gov...
Though only recently issued, the final guidance document on design considerations for home-use medical devices has been updated. Clarifying details have been added to sections pertaining to power mains and electromagnetic compatibility. As part of the Medical Device Home Use Initiative, the FDA recentl...
On October 18, 2018, FDA published draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.