Pathway Defense:
510(k) vs. Letter-to-File

The Bottom Line: A manufacturer modified a device and needed to know: "Do we need a new 510(k)?" Internal teams were deadlocked, with Commercial focused on launch timelines and Regulatory focused on keeping FDA confidence. No one wanted to gamble on a guess that might later be second-guessed by an investigator. Beacon Regulatory Services LLC provided the definitive regulatory logic, facilitated alignment between stakeholders, and authored a bulletproof "Letter to File" that captured the rationale in plain language for management while standing up to regulatory scrutiny for auditors.

The Situation

Business teams pushed for a rapid launch of a modified device, assuming the changes were "minor" and already factored into commercial forecasts. Regulatory stakeholders, however, recognized that even a seemingly modest design or labeling adjustment can trigger FDA questions under the "Significant Change" framework. Internal meetings circled the same questions: Would FDA see this as a new intended use? Did the risk profile shift in a meaningful way? Was a conservative 510(k) submission the safer option, even if it meant delaying revenue by six months or more? The project was gridlocked, and leadership needed a clear, defensible answer—not just opinions.

The BRS Intervention

• Trigger Analysis: Mapped the change against 21 CFR 807.81(a)(3) flowcharts. BRS walked the client through a structured, question-by-question analysis—covering indications for use, technology, performance, and risk—so that each assumption was documented and pressure tested rather than debated informally in email threads.
• Labeling Review: Ensured claims remained within the original clearance scope. Marketing copy, IFU language, and any implied performance enhancements were compared line-by-line to the cleared 510(k) to confirm that the modified device would not be represented as something new in the eyes of FDA, customers, or auditors.
• The Memo: Drafted an audit-ready "Letter to File" citing specific guidance to justify the decision not to file. The memo translated regulatory logic into an accessible narrative: what changed, why it did not rise to the level of a new 510(k), which flowchart branches were considered, and how residual risks would continue to be monitored in post-market surveillance.

The Outcome

Confidence to Launch. The product launched on time without an unnecessary 6-month 510(k) review cycle, protecting both revenue and market commitments. Regulatory leadership gained a clear, documented rationale they could stand behind in front of auditors, notified bodies, or corporate review boards. If FDA ever asks, the team can pull a single file that shows the decision was thoughtful, anchored in guidance, and taken with full visibility across Quality, Regulatory, and Commercial—not a shortcut taken under schedule pressure.