Medical Device Data Systems | 合法醫療器材資訊網
2019年9月26日—MedicalDeviceDataSystems,MedicalImageStorageDevices,andMedicalImageCommunicationsDevicesGuidanceforIndustryandFood...theAgencydoesnotintendtoenforcecompliancewiththeregulatorycontrols ...
Docket Number: FDA-2014-D-0798[1] Issued by:Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
The Food and Drug Administration (FDA) recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology. The foundation for such inter-communication is hardware and software, typically referred...