<img height="1" width="1" style="display:none" src="https://www.facebook.com/tr?id=213807269037206&amp;ev=PageView&amp;noscript=1">

Compliance In Focus


Newest Post

Posted by John Lehmann on Wed, Mar 04, 2015

FDA Updates HDE Guidelines

FDA is updating guidance on its humanitarian device exemption program to clarify an expanded profit allowance and a potentially less-restrictive upper-limit on the number of qualifying HDE devices that can be sold for profit in a given year.

Topics: Safety and Innovations Act of 2012, FDA, Humanitarian Device Exemption

Posted by John Lehmann on Wed, Mar 04, 2015

Obstacles for Bionic Medical Devices

Chances are you may have seen an amputee or person with a disability with a sophisticated and complex medical device before.  What you probably didn’t stop to consider is where they got it and who created it?   Bionic medical devices are devices that have an electrical component which allows them to sense muscle contractions in the human body, then send electrical signals to nerves allowing a response.  Since bionic medical devices are devices by definition, they must also seek a pathway to FDA approval before they can be marketed in the U.S.  Given the small population of individuals, relatively speaking, who need these devices the most common pathway to approval is through a Humanitarian Device Exemption (HDE).  Like any pathway to marketing approval (510(k), Investigational Device Exemption, Investigational New Drug) there is a consider amount of research and development, and capital needed to achieve it.  Jamie Hartford, the managing editor of Medical Device and Diagnostic Industry (MD+DI) News Products and Suppliers recently published an online article outlining some of the common obstacles faced when working to achieve approval for these bionic medical devices.

Topics: MD+DI, Humanitarian Device Exemption, Bionic Medical Devices

Posted by John Lehmann on Fri, Jun 03, 2016

How Would You Make Humanitarian Device Applications Better?

FDA is currently seeking comments on the collection of information regarding the Humanitarian Device Exemption (HDE) applications and related requirements. As summarized by an article in MassDevice, the FDA is interested in learning:

Topics: Medical Devices, FDA, PMA, Humanitarian Device Exemption

Posted by John Lehmann on Wed, Mar 04, 2015

Cell Therapy Products… Falling into the HDE Category?

MedCity News released an article about Nanofiber Solutions development of scaffolds used for organ transplants. The company, a spinoff from The Ohio State University, boasts the first synthetic nanofiber transplant in the world, and hopes to grow in its market of artificial organ transplants.

Topics: technology solutions, cell therapy products, Humanitarian Device Exemption

Clinical Research Training Requirements
Featured Resource

clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.