FDA Launches eSTAR Pilot Program to Further Simplify Medical Device 510(k) Submissions

In what appears to be another electronic tool in the US Food and Drug Administration’s quest to move to full digital submissions for medical devices, the eSTAR program provides 510(k) applicants with a PDF template document to ensure submissions are complete and help reduce agency review time.

A promise from the US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) to further modernize its operations to keep up with technological advances continues to take shape with deployment of the electronic Submission Template And Resource (eSTAR) pilot program. eSTAR provides 510(k) applicants with a PDF template document to complete that will hopefully further reduce FDA review time (and thus allow for devices to enter the marketplace faster). On February 26, FDA announced that it will select up to nine medical device companies to participate in the program.

The pilot program builds on FDA’s existing eSubmitter platform launched in 2018. The eSubmitter platform is designed to guide users through the process of preparing a 510(k) submission to ensure that all the data FDA needs to make a decision is available. According to FDA, eSTAR—which eliminates the need for users to have software other than Adobe Acrobat—“includes similar benefits as eSubmitter, as well as additional benefits.” Created in an interactive PDF form, the 510(k) eSTAR template includes the following:

• Automation (e.g., form construction, autofill)
• Content and structure that are complementary to CDRH internal review templates
• Immediate access to FDA guidance documents and databases
• Guided construction for each submission section
• Automatic verification (i.e., FDA does not intend to conduct a “refuse to accept” review)
• Additional support for mobile devices
• Ability to share partially completed filings via email

FDA is currently looking for up to nine program participants that meet the following criteria:

• Plan to submit a 510(k) within three months of acceptance
• Have a body-contacting device that includes software (but not a combination device)
• Are willing to provide feedback on the eSTAR template and process to FDA

eSTAR should help FDA continue to improve its 510(k) review performance. Recent data released by FDA indicates that the agency achieved a 99.37% substantial equivalence determination within 90 days of 510(k) acceptance. FDA anticipated that with the eSubmitter program, the substantial equivalence determination timeline could be reduced from 90 days to 60 days. Once fully deployed, we anticipate that the eSTAR program will help FDA achieve a 60-day review timeline, thus allowing innovative products to enter the US market faster when compared to the current submission process.

How We Can Help

Morgan Lewis helps traditional and nontraditional medical device companies expedite the FDA approval process, design the least burdensome submission strategy, and ensure continuing compliance throughout the product’s lifecycle.

If you have any questions or would like more information on the issues discussed in this LawFlash, including applying to be part of the pilot program, please contact any of the following Morgan Lewis lawyers:

Washington, DC
Dennis Gucciardo
Michele Buenafe