On 12 September 2025, the US Food and Drug Administration (FDA) announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products. FAERS is an interactive tool that provides the public with real-time access to adverse events reports associated with cosmetic products.
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Entering the US market: understanding establishment registration & device listing
Accessing the US medical device market requires manufacturers to comply with several FDA obligations. One of the essential steps – after determining your device access pathway and receiving approval – is to register your company (establishment) and list your devices with the FDA.
Entering the US medical device market: classification and premarket pathways
Before launching a medical device in the US, manufacturers must understand FDA classification and select the appropriate premarket pathway. This guide outlines key steps for successful market entry.