FDA APPLICATIONS

FDA APPLICATIONS/ SUBMISSIONS

E & E Medicals helps its clients during the process of submitting applications for class I, II, III medical devices at any stage of the product development. Our qualified team of experts will successfully prepare and submit FDA medical device regulatory documents for U.S and international clients. These applications includes;

 
  • 510(k) Premarket Notifications
  • Premarket Approval Applications (PMAs)
  • 513(g) Requests for Classification
  • Investigational Device Exemption Applications (IDEs)
  • Investigational New Drug Applications (INDs)