Five Common Mistakes Submitting a Premarket Notification

How you can avoid the most common errors made when submitting a 510(k), the “premarket notification,” with simple measures

FDA 510k Premarket Notification: Essential Requirements

Common Intra-Day Stock Market Patterns

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

Common Entry Submission Errors

FDA Releases New Cybersecurity Premarket Guidance

FDA: The 510(k) clearance (Premarket Notification)

Obtaining FDA 510k Clearance for Class II Medical Devices

Special Report: FDA's proposed rule to bring LDTs into the fold

Five Common Mistakes Submitting a Premarket Notification

The De Novo Classification Process A Work in Progress

510(k) Pre-Market Notification Project

Medical Device Academy Blog Archive