We Submitted a 510(k) in 7 Weeks and Cleared it in 4 Months

The Outcome

510(k) submitted in 7 weeks — one week ahead of an 8-week deadline. FDA clearance December 20, 2024, ~4 months after submission and 6 months after project kickoff.

The Problem

Medweb came to us with a zero-footprint DICOM viewer and a hard deadline: clear the device in time for RSNA 2024. They needed a complete Design History File and 510(k) submission package built in eight weeks on top of engineering work that had never been packaged for FDA. No in-house regulatory writing capacity to hit that timeline alone.

What We Did

• Read the existing user manual and test cases. Reused them to author user needs, requirements, device description, substantial equivalence rationale, and verification test plans instead of starting from scratch.
• Ran a software safety and cybersecurity gap analysis. Specified the remediations needed to meet FDA expectations.
• Scoped the device tight. Recommended excluding several candidate features and the Medweb backend from the medical device boundary which simplified predicate selection, lowered the risk classification, and shrank the document set.
• Translated the document set into language Medweb's team could review and own. No jargon walls. No template overwhelm.
• When FDA challenged a feature during review, we saved the day by brokering a deal between the client and FDA to still allow the FDA clearance through. Trade-off: a narrower first clearance, with a clean foundation to add the feature back through a follow-on submission.

Timeline

• June 18, 2024 — Project kickoff
• August 8, 2024 — 510(k) submitted (1 week ahead of schedule)
• October 7, 2024 — Additional Information (AINN) request received
• November 21, 2024 — AINN response submitted
• December 20, 2024 — 510(k) cleared