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 5: Administrative Review

    After the scientific review is completed, the reviewer's recommendation is forwarded to the division director for concurrence.
    Before an SE letter can be issued for a class III device, ODE will contact the CDRH Office of Compliance (OC) to verify the current Good Manufacturing Practices (GMP) status of the 510(k) submitter. The purpose of this process is to prevent issuing marketing clearances to 510(k) submitters with significant GMP violations, reasonably related to the device, that could result in the production of unsafe and/or ineffective devices until such time as the device related violations are corrected.

    When a 510(k) is received for a Class III device in the DMC, the OC is notified. The 510(k) takes its normal route through the ODE while the OC contacts the 510(k) submitter and the FDA District Office to confirm the current GMP status of the manufacturer.

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