http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/eMDR–ElectronicMedicalDeviceReporting/default.htm. 如何确定eMDR是否提交成功 FDA的系统会自动把3封独立的电子确认信发到用户的ESG账户。这些确认结果表明eMDR到达的处理阶段: 确认信1也称为收信或MDN(信息处理...
FDA Issues Draft Guidance on Medical Device Reporting for ManufacturersTyler, Lynn
Public Notification of Emerging Postmarket Medical Device Signals Here's the “B-list”, or the list of guidance documents intended for publication as FDA's resources permit: Final Guidance Topics Reporting of Computational Modeling Studies in Medical Device Submissions ...
(Feb. 21). Tammy Beckham, associate director of the resilient supply chain and shortages prevention program in FDA’s Center for Devices and Radiological Health, said FDA wants to find new opportunities for the agency to provide guidance and flexibility to manufacturers to help avoid shortages. ...
https://www.fda.gov/food/guidanceregulation/retailfoodprotection/foodcode/default.htm FDA Facts About Current Good Manufacturing Practices (CGMPs) - https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps FDA Overview of Device Regulation - https:...
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085994.htm. Accessed January 13, 2011 5. US Government Accountability Office, FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process: GAO-09-190: ...
FDA法规简介https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance FDA UDIhttps://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system#ruleguidance
g for Manufacturers FDA Releases Final Guidance on Medical Device Reporting for ManufacturersFDA Releases Final Guidance on Medical Device Reporting for ManufacturersAllison W. Shuren
FDA’s guidance documentData Integrity and Compliance With Drug CGMPfor guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-dru...
2014 Final Guidances Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and FDA Staff Medical Device Tracking: Guidance for Industry and FDA Staff ...