Analysis of 24,000+ FDA 510(k) records reveals trends

On average it took 166 days (nearly 5 months) for the FDA to review and clear a 510(k) in 2013;

Still faster than many major markets…You may be interested to know that as part of EG’s 2014 Medical Device Industry Survey they asked 1,400 QA/RA professionals to rate the most challenging Regulatory markets.  The results were pretty clear.  China, Japan, and Brazil stood out – along with the US – as being difficult markets to gain approval.   Yet despite the headaches of going through a rigorous FDA review process, it is still faster to gain 510(k) clearance than gaining the same approval in China, Japan, Russia or Brazil.  More than 2/3 of all 510(k) submissions clear within 6 months.

REFERENCE:  Emergo Group; Chris Schorr; 14 FEB 2014

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