MDUFMA requires that no more then 15 persons be accredited during the 12 months that follows the publication of this guidance.

MDUFMA的要求是：本指南发布后12个月内，受到认可的人数不多于15人。

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The comparable legislation that mandates user-fee waivers for small medical device companies, the Medical Device User Fee and Modernization Act (MDUFMA), specifies different criteria: Whether or not a company is small is determined by gross receipts or sales for the company and affiliates.

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