FDA/CDRH Changes: How SaMD, AI/ML & Connected Device Companies Can Prepare
Date & Time: Mar 26, 2025 12:00 PM in Eastern Time (US and Canada)
Description:
Significant changes are underway at the FDA, with staff and policy shifts creating uncertainty for MedTech companies. With updates continuing through 2029, proactive manufacturers should rethink their regulatory strategies to stay ahead of a winding curve that may take sharp turns.
The challenge? Knowing what’s changing, what remains unclear, and what actions to take now.
Join Orthogonal and a panel of former FDA regulatory staff turned industry experts for a pragmatic webinar. They’ll break down key updates from HHS, the FDA, and CDRH into clear, practical takeaways to help you navigate regulatory shifts while developing clinically and commercially successful digitally enabled medical devices.
What We’ll Cover:
✔️ What’s Happening at the FDA? – What we know, what we suspect, and what remains unclear.
✔️ Impact on Digitally-Enabled Devices – How shifts affect SaMD, AI/ML-enabled, and connected devices, plus key steps to take now.
✔️ HHS Rulemaking Changes – The impact of eliminating public comment periods for certain administrative rules.
✔️ Potential QMSr Updates – What could change with QMSr and how to prepare.
✔️ Breakthrough Device Program Impact – What these shifts mean for future approvals.
✔️ Post-Market Regulation Changes – How evolving policies could affect inspections and compliance.
✔️ Will the FDA Remain the Regulator of Choice? – Are manufacturers shifting to the EU or other global markets first?
✔️ Finding Opportunity in Uncertainty – How manufacturers can adapt and create new paths to success.
Who Should Attend?
▪️ Regulatory & Quality Leaders – Stay ahead of changing FDA requirements and compliance expectations.
▪️ Executives & Business Leaders – Understand the impact on market access, approval pathways, and commercial success.
▪️ Product & Engineering Teams – Learn how to align AI/ML or SaMD products with new regulatory expectations.
Don’t let regulatory uncertainty slow your path to success.
Register now for expert insights.