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Wellkang® LLC |
World Leading Consultancy in
FDA 510(k), UL, CCC Mark, CE Marking |
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Your One-Stop Reliable Partner in International Trade! |
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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 2: Division Acceptance Criteria (Part B)
If the recommendation to accept has concurrence, the 510(k) will be assigned to a
division reviewer. In this case, you will not receive an acceptance letter.
If the recommendation not to accept has concurrence, a Refuse to Accept letter,
detailing the omissions and inadequacies, will be mailed to the submitter or applicant. The letter will
specify what information must be submitted if the applicant wishes to pursue clearance for
marketing.
If you receive a Refuse to Accept letter, send FDA the required
information or a letter requesting an extension of time to obtain the information
requested to the DMC within 30 days. If neither is received within 30 days,
the 510(k) may be deleted from the system. In this case another 510(k) will
be required for you to pursue FDA marketing clearance.
Click here to continue...
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