FDA Device eSubmission Pilot

The FDA is accepting requests to participate in its Medical Device eSubmission pilot program. This is only open for devices being submitted to ODE’s Division of Cardiovascular Devices Cardiac Diagnostic Devices Branch or Peripheral
Interventional Devices Branch. This will be interactive to evaluate the process/tools and the Refuse to Accept screening will be waived for participants. Deadline for requests to participate is September 30, 2014.

Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
Non refundable but transferable.

Or just email training@softwarecpr.com for more info.

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