Vivos Inc (RDGL)

[kheath39]

http://bmtadvisors.com/docs/2010_06_10_FDA%20Review%20Patterns%20of%20De%20Novo%20Submissions_Final.pdf


FDAMA calls for the FDA to review and return a decision on a De Novo reclassification submission within 60 days of receipt (the initial submission must be sent by the manufacturer within 30 days of receiving NSE notification). In practice, however, the amount of time taken to review De Novo requests by the FDA and issue the special controls guidance has risen from 62 days in 2006 to 241 days since 2007. Tacked on to the 510(k) review times, devices traveling the De Novo pathway average 482 days of review time from beginning to end.[color=red][/color]


Where is everyone getting 120 days from