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Re: None

Monday, 10/19/2015 11:24:58 PM

Monday, October 19, 2015 11:24:58 PM

Post# of 331891
Per provisions of FDASIA, Food and Drug Administration Safety and Innovation Act, the FDA must complete 95% of the 510k submissions received in 2015 within 90 days.

BIEL's submission date was 8/6/2015.

"FDA has committed to review 91% within 90 days for FY 2013 (compared to 90% in 90 days for FY 2012); 93% within 90 days for FY 2014; and 95% within 90 days for FYs 2015 - 2017."