FDA 510(k) Submission Process Timeline/Overview

The FDA page at the link provided provides an overview of the 510(k) review process and timeline. It describes the acknowlegment procedure, Acceptance Review, Substantive Review, Interactive Review, AI Request and Decision Letter. It also provides a timeline and indicates all timeframes are in calendar days. Full Manual Link: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm

Upcoming Training

QSS Software Validation
Planned Instructors:  Brian Pate, John Murray
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)! 

Multi-Student Discounts as well!

Email training@softwarecpr.com
to receive discount

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.