New FDA Guidance on Medical Devices: Enhanced Reporting Requirements for Adverse EventsGilmore, Melissa
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FDA Drafts Guidance on Inspections of Medical Device Establishments The US Food and Drug Administration (FDA) issued draft guidance on Thursday to implement uniform processes and standards for FDA inspections of domestic and foreign medical device establishments.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...
Ultimately, the new Draft Guidance seeks to enable manufacturers to market medical devices with continuously learning algorithms without having to obtain a new authorization or clearance for each change, so long as the changes are in line with the predetermined plan. Through this Draft Guidance, FDA...
New FDA draft guidance on medical device panel meetings generally confirms current practices, provides additional detailGerard J. Prud'hommeKristin M. Zielinski
FDA Updates Guidance on Devices in the Magnetic Resonance Environment Draft guidance issued on Thursday offers updated testing and labeling advice to assess the safety and compatibility of medical devices for the magnetic resonance (MR) environment. ...
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. ...
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...
(FDA) has released guidance in the past about security in medical devices, the pace of technology warrants more frequent guidance documents. The latestFDA cybersecurity guidanceto be released is still in the draft stage, “Cybersecurity in Medical Devices: Quality System Considerations and Content ...
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...
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...