Vivos Inc (RDGL)

[boatlife]

2014 De Novo Guidance, draft
Major Items
• explains changes to FD&C Act:
§ allowed alternative pathway that doesn’t require submission of a
510(k) prior to de novo request
§ timeframe for review set at 120 FDA days
• Decision Options: grant or decline
• Pre-Submission meeting process
• new term: “direct de novo” (no 510(k) prior to de novo
submission)


so again IMO the 120 does NOT count holidays as it states FDA DAYS wich IMO means FDA BUSINESS DAYS