The CDRH 510(k) eSubmissions Pilot Program is a new voluntary route for submitting 510(k) applications that guides the user through constructing and submitting a 510(k) submission electronically, eliminating the need for a hard copy or a compact disc.
Pilot submissions will help refine the process by which CDRH gathers data and documents, and it will ensure that the software infrastructure functions work properly.
This Pilot has ended, and only applicants that have already submitted submissions can continue to submit documentation via the eSubmitter template.
Participation in the CDRH 510(k) eSubmissions Pilot is voluntary and open to sponsors whose submissions are reviewed in all branches of the Office of Device Evaluation’s (ODE) Division of Cardiovascular Devices, Division of Neurological and Physical Medicine Devices, Division of Orthopedic Devices, and the Division of Surgical Devices.
We encourage 510(k) sponsors of all device types, including those reviewed in other divisions, to review the eSubmitter user interface and provide feedback to us at eSubpilot@fda.hhs.gov. We will evaluate participation in the pilot to determine the need to expand to include other device types.
The FDA will accept requests for participation in the CDRH 510(k) eSubmissions Pilot through December 31, 2014, or as resources and the CDRH 510(k) eSubmissions Pilot needs allow. The FDA is limiting the CDRH 510(k) eSubmissions Pilot to no more than 100 submissions and may further limit the number of submissions from an individual firm.
Sponsors interested in volunteering to participate in the CDRH 510(k) eSubmissions Pilot should email the CDRH 510(k) eSubmissions Pilot staff at eSubpilot@fda.hhs.gov and include the name of the device, theprimary product code, and any identified predicatesin the email.FDA will only accept 510(k) eSubmissions from sponsors that first contact us at this email address and are accepted into the pilot.
Once sponsors are accepted into the pilot, they should follow the CDRH 510(k) eSubmissions Pilot User Guide for the process of submitting a 510(k) eSubmission.
Please send any questions or feedback to eSubpilot@fda.hhs.gov.
- Overview of CDRH 510(k) eSubmissions Pilot Program
- CDRH 510(k) eSubmissions Pilot User Guide (PDF - 498KB)
eSubmitter 510(k) Template Evaluation - One Pager(PDF - 255KB) Creating Digital Signatures Quick Guide(PDF - 157KB)
- Federal Register Notice: eSubmissions Pilot Program
- CDRH eSubmission Pilot Program Overview Video (MP4 - 16MB)
- eSubmission Template Training Video (MP4 - 61MB)