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.
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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.
Washington State proposes new rule to restrict formaldehyde in cosmetic products
Washington State proposes a rule to restrict formaldehyde and FRAs in cosmetics. Learn about the potential impact.