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