The FDA’s 2027 establishment registration renewal period is now open. Medical device manufacturers must renew their registration by 31 December 2026 to maintain compliance and US market access. Discover the updated FDA fees, key deadlines, and essential renewal requirements.
The U.S. FDA has replaced the former Quality System regulation with the new Quality Management System Regulation (QMSR), effective 2 February 2026. By incorporating ISO 13485:2016 into 21 CFR 820, the FDA aligns U.S. medical device quality requirements with internationally recognised standards.
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.
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.
