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FDA Review Process...
Each year, the week before Thanksgiving in Chicago, the RSNA trade show occurs. This is reputed to be the largest medical device show in the world, by a sizable margin. Each presenter in Chicago wishes to claim his application for new products has been submitted to the FDA. This event causes a seasonal peak of submissions that you will want to factor into your plans. We advise clients that if your submission is at the FDA prior to the occurrence of this peak, then your application must move in front of the others. This peak starts in middle of September, builds into October and ends in November. This accounts for about 1/3 to 1/2 of the 5,000 or so 510(K)'s the FDA receives each year. Being in front of this peak can save you six months of review time at the FDA.

Other than this the best occassions to actually have your application in front of the FDA reviewer is three weeks before Christmas and in the month of July. We can explain to you each of these occassions and their impact on you.

As part of our fee, will work with you to ensure that your submission is filed around middle September to take advantage of the review season. This will require you to act on our proposal. Our process will require at least 60 days. You can do the math to set a time schedule.

copyright by Compliance Consultants, Stamford, CT USA, September 2001