FDA to Pilot Interactive 510(k) Template

As part of its commitments under the Medical Device User Fee Amendments (MDUFA IV), the US Food and Drug Administration (FDA) on Wednesday announced a pilot to test a new, interactive, PDF-based 510(k) template.
 
According to FDA, the electronic Submission Template and Resource (eSTAR) features automation, integration with other resources and a structure that is more aligned with the Center for Devices and Radiological Health’s (CDRH) internal review templates.
 
For the pilot, FDA is seeking nine companies to participate “who provide a holistic representation of the medical device industry” and who will submit at least one traditional, special or abbreviated 510(k) using eSTAR within three months. Participants must also intend to submit a 510(k) for a device that comes in contact with body tissue and includes software and must be willing to provide feedback on eSTAR to the agency.
 
“Without changing our statutory or data requirements, this highly-interactive submission template is intended to allow manufacturers to provide information to the FDA that’s complementary to CDRH internal review templates,” said CDRH Director Jeff Shuren.
 
The pilot will be run in parallel with another 510(k) pilot, the Quality in 510(k) Review Program Pilot, which is being conducted to test FDA’s eSubmitter submission template.
 
FDA says it plans to evaluate whether eSTAR produces submissions “that can be reviewed more efficiently, in comparison to submissions prepared as eCopies or with the eSubmitter application,” and notes that eSTAR was designed to deliver benefits beyond the eSubmitter platform, including a more intuitive interface, support for images, popups, mobile devices and Apple iOS support.
 
Additionally, FDA says the eSTAR platform includes automatic verification and that it does not intend to conduct a refuse to accept (RTA) review on submissions under the pilot.
 
FDA also notes that it will not accept 510(k) submissions for combination products as part of the pilot.
 
FDA, Federal Register Notice