Submitting a 510(k)? Keep Hoarding Blank CDs

FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency.  An eCopy is an electronic copy of the 510(k) that is comprised of files created by the sponsor, with the exception of several FDA forms, and is submitted to the Agency by saving to a CD, DVD or flash drive and mailing or otherwise physically delivering the media to FDA.  The biggest drawback of an eCopy, in our opinion, is the need for physical delivery to the Agency, versus being able to electronically deliver the files.

In September 2018, FDA took its first step towards electronic 510(k) submissions with its Quality in 510(k) Review Program Pilot, which we blogged about here.  This pilot program, which utilized FDA’s eSubmitter electronic submission template, ended in May 2021.  As that program was underway, FDA developed another pilot program for electronic 510(k)s using the electronic submission template and resource (eSTAR).  Both of these electronic templates were free to use and offered:  automatic construction and auto-filling content; content and structure that is complementary to CDRH internal review templates; integration with FDA databases and guidance documents; and automatic verification.  While eSubmitter is a proprietary application that requires training, eSTAR uses Adobe Acrobat Pro.  eSTAR also offers some additional technical improvements, such as the ability to add comments to the PDF.

Section 207 of the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-521 ) amended Section 745(A)(b) for the Federal Food, Drug, and Cosmetic Act (FD&C Act) to include that after publication of a final guidance, pre-submissions and 510(k)s “shall be submitted solely in such electronic format as specified by the Secretary in such guidance.” FD&C Act Section 745(A)(b)(3)(A).  On September 29, 2021, FDA took another step towards electronic submissions with release of the draft guidance, Electronic Submission Template for Medical Device 510(k) Submissions (Draft Guidance).  The Draft Guidance provides FDA’s interpretation of the statutory requirement for submission in electronic format.  It defines an electronic submission, or eSubmission, as a “submission package produced by an electronic submission template that contains the data of a ‘complete’ submission.” Draft Guidance at 8.  One might be surprised, as we were, that an electronic submission does not entail electronic transmission of the 510(k) files to the Agency.

The guidance explains that, when final, 510(k)s would need to be provided as an electronic submission prepared with the current eSTAR template.  It does not appear that any changes to the eSTAR template are proposed at this time.  The Draft Guidance provides an outline of the eSTAR structure, but does not include important details, such as which content of the 510(k) will be structured data, meaning data and content that are captured in the fields, dropdown boxes, checkboxes, etc., within the eSTAR template, and which content will be unstructured data that will be submitted as attachments to the electronic submission.  In our development of 510(k)s, sections such as the Device Description and Substantial Equivalence Discussion, are prepared over multiple iterations of revisions with a cross-functional team.  The ability to track changes and provide and respond to comments is an important part of this process.  These sections can also be quite lengthy, especially for complex devices and systems, and often incorporate many figures and tables which can be difficult to format outside of traditional word processing applications.  We hope that the final guidance and template will ensure the ability to easily attach documents outside of the template to minimize impact to development workflows.  The eSTAR outline in the Draft Guidance includes references to topical guidance documents for each section, but it is also not clear if the template will use the structured forms to ensure content from these guidance documents is addressed, or if it provides only a reference to be used by applicants to prepare unstructured content containing recommendations from these guidance documents.

The Draft Guidance indicates that “the electronic [510(k)] submission must still be saved to a form of electronic storage media and mailed to FDA.” Id. at 13.  Thus, the 510(k) created with the eSTAR template is not actually submitted electronically to the Agency.  We’re disappointed that this much needed aspect of a truly electronic submission is still missing.  So, while we wait for the 510(k) process to catch up with current technology, keep your computers with CD/DVD burners well maintained for now and your blank media stocked.  We hope you don’t need to copy over “Road Jamz 2005,” as John Oliver worried about in his episode of Last Week Tonight that addressed this important issue as it related to submission of Emergency Use Authorizations early in the COVID-19 pandemic.