Dive Brief:
- The Food and Drug Administration has published two guidance documents on the structure of electronic filings for 510(k) and de novo clearances.
- In a final guidance issued on Monday, the FDA identifies Oct. 1, 2023 “as the date on which the 510(k) electronic submission requirements will take effect.” The FDA will set a date for de novo requests within two years, according to a separate draft guidance.
- The documents advance the transition to eSTAR, an electronic submission template that the FDA is implementing in response to legislative requirements and its MDUFA commitments.
Dive Insight:
Legislation passed in 2017 required the FDA to use an electronic format for premarket submissions. The agency has since worked to move to a new system, starting an eSTAR pilot early in 2020 and expanding the initiative over the following years. Now, the FDA has published two guidance documents to inform electronic submissions.
One of the documents is a final guidance on the electronic submission template for 510(k) submissions. In the guidance, the FDA presents a table of the information requested by eSTAR, such as a description of the device and the proposed indications, and covers the types of details applicants should include.
The FDA has published a similar table in its draft guidance on electronic de novo requests. Some parts of the two templates are identical, but there are sections that are specific to each filing type, such as a request for information on predicates and substantial equivalence in the 510(k) form and a box about benefits, risks and mitigation measures in the de novo form.
Officials have more experience using the system with 510(k) filings than with de novo requests. The template has been available for voluntary use with 510(k) filings since 2020, and the de novo template was added in 2022.
In the final guidance, the FDA identifies Oct. 1, 2023 “as the date on which the 510(k) electronic submission requirements will take effect.” The FDA will set a date for de novo requests within two years.