Insights That Move You Forward

Helping you make smarter decisions, avoid costly missteps, & bring safe, effective products to market with confidence

Michael Nilo 10/1/25 Michael Nilo 10/1/25

How a Government Shutdown Affects FDA Medical Device Regulation

Government shutdowns don’t completely stop the FDA—but they do create unpredictability. While essential functions like recalls and safety monitoring continue, new submissions, inspections, and policy development often stall. Learn what history tells us about shutdown impacts and how device makers can prepare.

Crystal Norwood 6/15/25 Crystal Norwood 6/15/25

What to Expect from an FDA Pre-Submission Meeting

FDA Pre-Submission meetings offer critical insight into regulatory expectations before you invest time and budget. From strategy planning to meeting facilitation, NMCG helps sponsors maximize feedback, reduce delays, and approach FDA reviewers with confidence and clarity.