A Look at U.S. Market Regulations Through a Recent FDA Warning Letter “An FDA warning letter? That's only for big corporations, right?”...

Have you ever had a seemingly perfect product unexpectedly delayed or detained at customs? One of the most common reasons for this is a...

On July 30, 2025, the U.S. FDA announced the Medical Device User Fees applicable for Fiscal Year 2026 (October 1, 2025 – September 30,...

February 5, 2025 Risks of Not Having an FDA Initial Importer When importing medical devices into the United States, failing to designate...

October 18, 2024 When bringing a product to market, one of the most important steps is figuring out how the FDA categorizes your product...