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Wellkang® LLC |
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510(k) Submission Process |
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News - “US Agent” Needed |
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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.
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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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