Wellkang® LLC
  • Introduction

  • List of Official Steps:
    1. Log-in Procedures
    2. Division Acceptance Criteria
    3. Reviewer Assignment
    4. FDA Requests for
      Additional Information

    5. Administrative Review
    6. Decision Letter Issued
  • 510(k) Status Program

    February 11, 2002:

    The FDA requires that all non-US medical device manufacturers wishing to market their products in the United States must have a local representative in the US, i.e. the “US Agent”.

    Wellkang LLC is your reliable “US Agent” in dealing with FDA.



      Step 3: Reviewer Assignment

    Several things can affect how quickly 510(k)s are reviewed, such as:
    • IDEs and PMAs have statutory due dates and therefore take priority over 510(k)s;
    • 510(k)s and PMAs granted expedited review are taken out of turn and reviewed first;
    • If additional data is requested from FDA by letter, the application is put on hold; and
    • Consulting review of 510(k)s by another CDRH office or another FDA Center.

    Click here to continue...

    | Home | Services | Our Clients | About Us | Online Shop | Contact Us | Partners & Links |

    Copyright© 2004 - 2006 Wellkang® LLC - Member of Wellkang® Group
    All Rights Reserved. Terms of Use, Copyright& Disclaimer.
    Some information at this site is obtained from websites & publications of FDA
    Last updated on
    Melbourne, Florida, USA