A new pilot program by CDRH will allow participating medical device sponsors to electronically submit 510(k) notification materials through an electronic portal similar to the approach used for online tax filings. The purpose of the eSubmissions Pilot is to make the 510(k) process more user-friendly and eliminate the need for hard copies, while increasing the level of regulatory compliance. Data will be submitted through a "guided interface" that closely tracks FDA regulations, helping ensure every relevant requirement is met. For now, participation in the CDRH pilot is limited to unbundled, traditional 510(k) submissions for classified devices that will be reviewed by the Cardiac Diagnostic Devices Branch or Peripheral Interventional Devices Branch. FDA has provided a helpful user guide detailing the eight-step eSubmission process. Sponsors interested in participating must submit a letter of interest to CDRH by September 30.
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