The FDA Center for Devices and Radiological Health Office for In Vitro Diagnostic Devices has been promoting use of electronic 510(k)s. The link above provides information as well as links to FDA’s CeSUB esubmitter software and user manual.
IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.
October 13-15, 2026
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