Search for:
  • Home/
    • Tag: FDA labeling compliance

510(k) Premarket Notification & Clearance Support – XPRO AMERICA

The 510(k) Premarket Notification is the primary FDA submission pathway for most Class II medical devices. It demonstrates that a new device is substantially equivalent to a legally marketed predicate device. Proper preparation, documentation, and FDA interaction are critical for timely clearance and market access in the United States. At [...]

Tags:
Read More

USFDA Establishment Registration – XPRO America – Food, Drugs, Cosmetic, Medical Devices – Alternative to Registrar Corp

USFDA Registration Services @XPRO AMERICA – Simplifying Your Path to the U.S. Market If your business aims to export food, cosmetics, dietary supplements, or medical devices to the United States, obtaining a USFDA Establishment Registration is a mandatory step. This process ensures your facility is recognized by the U.S. Food and Drug Administration (FDA) and is compliant [...]

Tags:
Read More