MethodSense Intelligence Brief – Q1 2026
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MethodSense Intelligence Brief – Q1 2026
2025 Successes and What They Signal for 2026 Regulatory expectations accelerated in 2025. As FDA scrutiny increased, many innovative medical device companies encountered regulatory challenges that threatened timelines, funding, and market plans. MethodSense was engaged to restore regulatory confidence, reduce execution risk, and reestablish momentum. In this newsletter, you will learn about how MethodSense is…
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Regulatory Outlook 2026: Discipline, Data, and Regulatory Intelligence
What regulatory shifts in AI, cybersecurity, digital submissions, and capital strategy mean for your success in 2026…By Rita King, CEO & Senior Regulatory Strategist, MethodSense As we enter 2026, one thing is clear: regulatory success is no longer about reacting well. It is about preparing deliberately. The FDA’s expectations have not fundamentally changed. But the…
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eSTAR Submissions, a New Method for US FDA Medical Device Submissions
Identifying and Overcoming eSTAR Challenges for a Successful Submission As of October 1, 2023, all 510(k) submissions must be submitted as electronic submissions using eSTAR through the CDRH Portal for CDRH or the Electronic Submission Gateway (ESG) for CBER. eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive…