The Center for Devices and Radiological Health (CDRH) provided its users with a web page including all the useful information for companies on the “Small Business” program. Through the “Small Business Program” companies submitting notifications to the FDA (510 (k), PMA, etc.) will be granted with a reduced filing fee and a more than halved fee to pay for the practice review.

The lack of a turnover of more than US$ 100 million in the reference tax year represents a key requirement for “Small Business” qualification. If the Manufacturer had affiliates or was part of a group, the total turnover would be considered.

Facilitating and disseminating information about this possibility is likely to be a consequence of registration fees increase which, in some cases, as in 510(k) procedure, undergone an increase of nearly 50%. The dissemination of the Small Business web page information could indeed allow medium-small companies that cannot afford substantial investments to enter the US territory with their products.


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