NetworkNewsBreaks – FDA Grants Small Business Status to Cytori (NASDAQ: CYTX)
Cytori (NASDAQ: CYTX) has been granted Small Business status for fiscal year 2017 by the U.S. Food and Drug Administration Division of Industry and Consumer Education. The designation allows Cytori to receive substantial financial incentives, fee reductions, and fee waivers for selective FDA medical device regulatory filings. The company is also eligible for a substantial reduction in many medical device user fees and a one-time waiver of the user fee for its first premarket approval (PMA) application, potentially occurring later in 2017. “Cytori Cell Therapy benefits from being regulated as a device through the PMA process. The small business designation…







