Pathways' Pick of the Week: Electronic 510(k)s Coming Soon

Starting in October 2023, the only way to submit a 510(k) will be using CDRH’s eSTAR electronic template and submitting it via the center’s online portal. That might not seem like such a big deal in the context of today’s online economy and virtual workplaces, but it represents a major milestone in the device center digging out of its aging IT systems.

FDA issued a guidance document September 21 that sets October 1, 2023, as the date by which companies must make electronic 510(k) submissions. The device center started piloting the PDF-based electronic Submission Template And Resource, or eSTAR, template in 2020 and says it is an effective tool to help sponsors submit a complete 510(k). More recently, CDRH opened up its new Customer Collaboration Portal for some companies to submit eSTAR 510(k)s online, rather than having to upload the file to a thumb drive or CD and mail it in. By next October, that will be the only game in town for traditional, abbreviated, and special 510(k)s. “All 510(k) documentation will need to be submitted via the CDRH Portal and all 510(k) submissions will need to use eSTAR,” an FDA spokesperson confirmed to Market Pathways. The new guidance explains that FDA does not plan to conduct a standard “refuse to accept” vetting process for electronic 510(k) submissions, but it will employ a virus scanning and technical screening process within 15 days of receiving the submission. Although eSTAR is also currently available for voluntary use with de novo submissions, the next-October requirement only applies to 510(k)s. In addition to increasing efficiency at FDA, regulators are also looking to eSTAR to support more globally harmonized premarket reviews.

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