Makers of medical devices will have to submit 510(k)s to the Food and Drug Administration electronically beginning in October 2023, a new guidance document from the U.S. agency says.
Through the 16-page guidance dated Sept. 22, manufacturers are being forcibly nudged to use the FDA’s electronic Submission Template And Resource – or eSTAR – template. The agency rolled out the free template in early 2020 via a now-concluded pilot program, and it’s the “only type of electronic submission template that is currently available to facilitate the preparation of 510(k) submissions as eSubmissions,” the guidance explains.
The FDA’s guidance, which finalizes a draft version of the document released in September 2021, satisfies a mandate by the FDA Reauthorization Act of 2017 (FDARA) that requires the agency to accept electronic submissions only.
The design and structure of an eSTAR is similar to templates used by FDA reviewers. An eSTAR doesn’t change the agency’s statutory or data requirements for sponsors to show substantial equivalence to predicate devices. Submitting via eSTAR will be voluntary until Oct. 1, 2023, at which time it will be the only way the agency accepts 510(k) submissions.
The FDA says in its guidance that requiring companies to submit electronically will “improve submission consistency and enhance efficiency in the review process.” Nevertheless, companies may elect to use a different approach if it “satisfies the requirements of the applicable statutes and regulations.” Firms that choose to go this route are being urged to contact the agency to discuss their alternative to using eSTAR.
The guidance further says the FDA doesn’t expect eSTAR submissions to fall under the agency’s refuse to accept policy for 510(k)s. However, an eSTAR will undergo virus scanning and a technical screening process to verify that the eSTAR submission accurately describes the device. Screening activities will also make sure that manufacturers include “at least one relevant attachment per each applicable attachment-type question” in their eSTAR.
For example, if software is a component of the product in question, the FDA will expect to receive a software description attachment in response to the eSTAR’s software description question.
The agency promises in its guidance that the virus scanning and technical screening process will take no longer than 15 days following submission.
The FDA also makes clear that it doesn’t intend to grant waiver requests to using eSTAR, and the agency says it will not accept other types of 510(k) submissions beginning in October of next year unless it permits an exemption.
In its guidance the FDA explains that, at this time, the only 510(k) submissions and information it will exempt are interactive review responses. The agency is also exempting specific amendments, including appeals and requests for supervisory review; substantive summary requests; changes in correspondent amendments; and amendments after a final decision, also known as add-to files.