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Friday, July 30, 2010 4:09:03 PM
510(k) Status Program
Submitters may request information on their 510(k) review status 90 days after the initial log-in date of the 510(k). Thereafter, the submitter may request status reports every 30 days following the initial status request. To obtain a 510(k) status report, the submitter should complete the status request form, FDA 3541, and fax it to the CDRH office identified on the form. Within three working days after a status request is received, CDRH will send the submitter a fax that includes:
* The ODE or OIVD division or branch to which the 510(k) is assigned;
* The last action, and date of action, that ODE or OIVD has taken regarding the 510(k);
* The position of the 510(k) in the reviewer's queue; and
* The average review time for the division or branch
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