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.

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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