JD Supra

FDA finalizes 2025 Q-Submission Guidance, streamlining interactions for device sponsors and proposes electronic submission mandate for Q-Submissions using eStar

On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” ...
MarketWatch

Enlil Introduces the Industry's First Evidence-Based Milestone View for Medical Device Companies to Streamline Development Phases and FDA eSTAR Prep

The MarketWatch News Department was not involved in the creation of this content. New capability delivers end-to-end traceability across all product development data, connecting milestones, decisions, ...
Morningstar

Enlil Introduces the Industry's First Evidence-Based Milestone View for Medical Device Companies to Streamline Development Phases and FDA eSTAR Prep

New capability delivers end-to-end traceability across all product development data, connecting milestones, decisions, and evidence across every phase of the medical device lifecycle. In an era of ...