| |
|
|---|
US FDA 510(k) APPROVAL CONSULTANCY
A. US FDA 510(k):
Comprehensive 510(k) submission services including substantial equivalence determination, predicate device identification, and preparation of complete submission packages.
B. Establishment Registration and Device Listing:
Complete support for FDA establishment registration, device listing, and annual renewal requirements for domestic and foreign manufacturers.
C. US Agent Service:
Professional US Agent services for foreign manufacturers, serving as your official FDA correspondent and ensuring ongoing regulatory compliance.
D. US FDA LABEL REVIEW:
Detailed review of device labeling to ensure compliance with 21 CFR Part 801 requirements, including content, format, and promotional claims.