+91 789 2456 581 | info@nckpharma.com

Pharma News

Keep updating your pharma knowledge
25 Feb 2016

What is Humanitarian Device Exemption?

In Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.

A device manufacturer`s research and development costs could exceed its market returns for diseases or conditions affecting small patient populations. The HUD provision of the regulation provides an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations.
To obtain approval for an HUD, an humanitarian device exemption (HDE) application is submitted to FDA. 

An HDE is similar in both form and content to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA.

Leave a Reply

Scale up your Pharma knwledge to Next Level with our Free Content

Case studies & Caselets
Simulation based learning
Online self competency assessment tests 

etc.