Free Market Report: U.S. Medical Device Clearance - Navigating the FDA 510(k) Premarket Approval Process for Medical Devices

Download now

Speed to market represents an important competitive advantage for medical device manufacturers, and can be a key factor in the total lifetime profitability of a new medical device.

This UL white paper discusses the challenges encountered by medical device manufacturers seeking market clearance under the FDA’s 510(k) program. The paper begins with an overview of the FDA’s various programs for the review of new or significantly modified medical devices, and a description of the information requirements for a 510(k) submission.

Author: UL LLC

Get instant access to this report! 

What is in the report

Copyright © 2016 UBM

I have read and accept the Privacy Policy *

*Required Fields

Fix the following errors: