Blog Posts by Jo-Ann Gonzales, RAC

To File or Not to File, That is the Question
New draft guidance on submission requirements for device changes
Monday, August 08, 2011

The Essentials of Essential Requirements
The challenging part is trying to figure out which strategy of meeting the essential requirements works best for the manufacturer.
Wednesday, December 08, 2010

Life on the A List
Requirements for List A products are similar to those for a PMA
Tuesday, November 09, 2010

Assessing Conformity
The route is determined by intended use and risks to personal and public health
Tuesday, November 02, 2010

Recent Blogs

The Dream of the 90s is Alive at CBER OraSure's at-home HIV test delivers on 20 years of effort

In-Vehicle Diagnostics Assessing the bold future of automotive medicine

Great New Companion Diagnostics E-Book Released Today A valuable resource in a hot, but under-informed segment of the market

Oragene Clearance Shows DNA Stabilization is Class II Clearance could have a significant impact on DTCG providers