510(K) Fee Management

The CRO Group does not just prepare 510(k)s. We also help you ensure that the 510(K)s are reviewed on time and in some cases, can help save your firm 20% of the review cost mandated by the U.S. Congress.

The FDA branch that reviews 510(K)s and PMA's does not begin its review until they determine that one very important thing happens: that is that the FDA got paid its user fee.

Although there are ways of eliminating and reducing the user fee, the FDA will not start the device review until after it's user fee review department agrees with the submitter that no fee or a reduced fee is required, and if a fee is indicated, the entire amount has been deposited in the FDA's bank account.

The CRO Group can help you save time and file the appropriate paperwork which is more akin to filing your taxes than a product submission and can take 2-4 weeks to be reviewed and approved, and can mean the difference between a 90 day and a 120 day review.

For more information on how CRO Group can be of assistance, please click here.

510(K) Fee Management

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