United States Food and Drug Administration (FDA) US Agent Service

M.Y.T. USA CORP is headquartered in Los Angeles County, California, USA. We provide FDA medical device establishment registration and U.S agent service to companies of every size on every continent, supplying them with viable and efficient development pathways and compliance solutions.

Our experienced team of U.S. local compliance consultants help manufacturers make timely and effective regulatory submissions; and remediate, maintain and improve regulatory compliance.

• FDA Medical Device Establishment Registration and US Agent Services        

  • Medical device establishment registration
  • ​Annual US agent communication service
  • ​Free modification 

   

  Medical Device Listings

  • Device listing service per product

   

  Emergency Use Authorization(EUA) to Respond to COVID-19

  • COVID-19 Diagnostic Test Kits
  • Filtering Face-Piece Respirator (FFR)-N95/ KN95 Face mask
  • Non-surgical isolation gown
  • Operating-room shoe cover
  • Surgical helmet
  • Surgical cap
  • Operating-room shoes
  • Conductive shoe and shoe cover
  • Surgical Gown
  • Hand Sanitizer
  • Sterilizer or Disinfectant
  • Other PPE

   

  FDA 510(k) Submission - PMN（Premarket Notification）

  • FDA 510k Process Guidance and Reviews(including testing list)
  • FDA 510k Documentation Preparation
  • FDA 510k Pre- Submission meeting with FDA
  • FDA 510k Documentation Reviews
  • FDA 510k Final Submission