FDA Interactive Model 510 (k) to Pilot


Posted on February 26, 2020 | Through Michel mezher

As part of its commitments under the Changes to fees for the use of medical devices (MDUFA IV), the United States Food and Drug Administration (FDA) on Wednesday announced a pilot project to test a new interactive PDF-based 510 (k) model.

According to the FDA, the Electronic Submission Model and Resource (eSTAR) features automation, integration with other resources, and a structure more aligned with the internal review models of the Center for Devices and Radiological Health (CDRH).

For the pilot, the FDA is seeking nine companies to participate “that provide a holistic representation of the medical device industry” and that will submit at least one traditional, special, or short 510 (k) using eSTAR within three months. Participants must also intend to submit a 510 (k) for a device that comes into contact with body tissue and includes software and must be willing to provide eSTAR feedback to the agency.

“Without altering our legal or data requirements, this highly interactive submission template is intended to enable manufacturers to provide the FDA with additional information to the CDRH internal review templates,” said Jeff Shuren, director of CDRH.

The pilot will run in parallel with another 510 (k) pilot, the 510 (k) Quality Review Pilot, which is being conducted to test the FDA’s eSubmitter submission model.

The FDA says it plans to assess whether eSTAR produces submissions “that can be reviewed more efficiently, compared to submissions prepared as electronic copies or with the eSubmitter application,” and notes that eSTAR was designed to offer benefits beyond the eSubmitter platform, including interface, support for images, popups, mobile devices, and support for Apple iOS.

Additionally, the FDA claims that the eSTAR platform includes automatic verification and that it does not intend to perform a refusal of acceptance review (RTA) on submissions under the pilot.

The FDA also notes that it will not accept 510 (k) submissions for the combination products under the pilot.

FDA, Federal Register Note

© 2021 Society of Regulatory Affairs Professionals.

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