US FDA Seeking Participants for 510(k) eSubmission Pilot
US medical device market regulators have begun accepting requests for participation in a pilot of their upcoming electronic submission program for 510(k) premarket notification applications.
The US Food and Drug Administration’s 510(k) eSubmission Pilot is open to manufacturers and sponsors of devices that would be reviewed by either the Office of Device Evaluation’s Division of Cardiovascular Devices Cardiac Diagnostic Devices branch or Peripheral Interventional Devices branch. The agency has limited participation in the pilot to traditional, classified 510(k) applicants; between 50 and 100 submissions will be accepted for the pilot, according to the FDA.
Requests for participation from qualifying manufacturers will be accepted through September 30, 2014. Those firms that do take part in the pilot will need to follow the Center for Devices and Radiological Health eSubmissions Pilot User Guide for electronically submitting their 510(k) applications.