eSTAR: 510(k) FDA submissions
In September 2022, the FDA has provided its latest guidance for 510 (k) regulatory submissions in an electronic format.
The electronic submission template is known as eSTAR.
This template is a collection of questions, text and prompts within a template that guides the user through construction of a 510(k) submission. The eSTAR template is highly automated and is integrated with FDA databases, in order to find the proper product code and recognised standards.
The submission will undergo a virus- screening scan and a technical screening process. In order to verify that the eSTAR responses accurately describe the device(s), and that there is at least one relevant attachment for each each applicable question that requires an attachment. This screening process takes a maximum of 15 days, and once the appropriate user fee has been paid (FDA 2023 user fees: https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa).
If the eSTAR template is not complete, the submitter will be notified by email, with the incomplete information identified. The 510(k)will then be placed on hold until a complete replacement is submitted.
For a submission that passes technical screening, the review clock starts on the day the submission was received by the FDA.
Furthermore, submissions made on eSTAR are not expected to go through a refusal to accept review, as the template will state if the information is complete.
Currently the eSTAR process is voluntary; but it will become mandatory starting from 1 October 2023.
Let us know if we can help get your device to the STARs...
Note: eSTAR is not to be used for combination products.
The electronic submission template is known as eSTAR.
This template is a collection of questions, text and prompts within a template that guides the user through construction of a 510(k) submission. The eSTAR template is highly automated and is integrated with FDA databases, in order to find the proper product code and recognised standards.
The submission will undergo a virus- screening scan and a technical screening process. In order to verify that the eSTAR responses accurately describe the device(s), and that there is at least one relevant attachment for each each applicable question that requires an attachment. This screening process takes a maximum of 15 days, and once the appropriate user fee has been paid (FDA 2023 user fees: https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa).
If the eSTAR template is not complete, the submitter will be notified by email, with the incomplete information identified. The 510(k)will then be placed on hold until a complete replacement is submitted.
For a submission that passes technical screening, the review clock starts on the day the submission was received by the FDA.
Furthermore, submissions made on eSTAR are not expected to go through a refusal to accept review, as the template will state if the information is complete.
Currently the eSTAR process is voluntary; but it will become mandatory starting from 1 October 2023.
Let us know if we can help get your device to the STARs...
Note: eSTAR is not to be used for combination products.
by Catarina Carrão
(aka Ana Catarina Ribeiro Carrão)