On September 26, 2019, the FDA released a new draft guidance document titled “Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.”
This guidance was published in order to be compliant with the provision set in FDA Reauthorization Act of 2017, which amended the FD&C Act to clarify that any medical devices under 510(k), 513(f)(2)(A), 515(c), 515(d), 20 515(f), 520(g), 520(m), & 564 of the FD&C Act, or section 351 of the Public Health Service Act should move to an electronic submission format. The act mandated that the FDA issue draft guidance no later than October 1st, 2019 to further clarify on the standards for these electronic submissions, as well as timetables for roll-out and criteria for waivers and exemption.
This brief, 10-page document appears to serve primarily as a starting point for the transition. The Agency clarifies that they have determined that it is not feasible to capture the standards for all submission types in a single guidance document. Therefore, separate guidance documents will be developed for each submission type that will clarify standards for electronic format, criteria for waivers and exemptions from the mandate, and overall timelines for implementation.
Below are the different submission types that will be affected by this initiative. Notably, the guidance stresses that once standards are fully established, any submission not provided in electronic format (unless qualifying for an exemption) will not be filed or received.
Comments can be made by the public for 60 days (Ending 25 Nov 2019) at www.Regulations.gov under docket number FDA-2019-D-3769.
WAYS reached out directly to CDRH this week to get more clarity on the planned structure for these electronic submissions. The electronic format that they are currently accepting is eCopy. eCTD 4.X (RPS) is one format that is being considering for future use. However, due to ease of availability for development and use, the agency has moved farther along with two other alternatives:
Use of the FDA application eSubmitter available for free to users. This is currently being used on the active Quality in 510(k) Review pilot.
Use of dynamic PDFs due to multiple reasons (e.g., applicant familiarity with PDFs, ease of development and use, better technology, more extensible). The electronic Submission Template And Resource (eSTAR) is an example of this. eSTAR was previously demoed to multiple industry trade organizations, and the feedback has been very positive. The agency is hoping to release eSTAR for comments, and then for testing as part of the Quality in 510(k) Review pilot in the coming months. eSTAR may attempt to mimic the format of the planned RPS package (according to the IMDRF nIVD and IVD TOC documents), but this has yet to be determined.
Though still in the early stages, this is an exciting development that the WAYS team will be keeping a close eye on. Electronic submissions for Drug Products have allowed for faster and more efficient reviews by Health Authorities, which can ultimately cut down on the timing for treatments to reach patients . We are confident that our accomplishments in the electronic submission realm will allow for a smooth transition and will be happy to assist sponsors in achieving compliance with this mandate.