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Practical interpretations of FDA enforcement trends, quality system expectations, and market entry strategies for device leaders.

Executive White Paper: The "Phantom" Listing Risk

What Investors and Strategic Buyers Expect from Your FDA Registration Story

Building a North America Regulatory Rail: Coordinating FDA, Health Canada, and COFEPRIS for Scale

Your Website, Your Labeling, and Your Device Listing: Why FDA Cares if the Story Doesn’t Match

What FDA Sees Before an Inspection: Red Flags in Your Establishment Registration and Device Listings

Cleaning Up Legacy FDA Device Listings After M&A, Distributor Changes, or Product Discontinuations

Annual FDA Registration Renewal: How to Get Through Oct–Dec Without Surprises

Avoiding Customs Holds: How FDA Registration and Product Codes Drive Clearance at the U.S. Border

Device Listings for OEMs, Contract Manufacturers, and Private Labelers: Whose Name Goes Where?

U.S. Agent, Importer, Initial Importer: Who Does What?

First-Time FDA Registration for Foreign Device Manufacturers: A 90-Day Playbook

Early Alerts, Faster Recalls — What FDA’s expanded Early Alert communications mean for your recall readiness

From Factory to FURLS: Step-by-Step FDA Registration and Listing for Device Manufacturers

FDA Inspections and Enforcement in 2025: What Recent Trends Mean for Your Quality System

FDA’s Latest Medical Device Recalls: Lessons for Small and Mid-Sized Manufacturers

Inside FDA’s Latest CDRH Annual Report: Trends Device Manufacturers Should Watch

AI and Software in Devices: Key Takeaways from FDA’s Recent Guidance and Initiatives

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