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 4: FDA Requests for Additional Information

    When the reviewer needs additional information to complete the review he or she will contact the applicant with a simple request or prepare a deficiency letter which will detail what additional information is needed.

    These written requests for additional information usually request a response within 30 days. If additional time is needed to gather the requested information, the 510(k) submitter may request an extension within the 30 days of FDA's request for information. Any information to be added to the 510(k) file must be submitted in writing to the DMC, clearly identified as additional information or a request for an extension of time, and must include the "K" number. The 510(k) may be deleted from the DMC database if there is no response to the request for additional information within 30 days of FDA's request letter.

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