Blog Posts by Jo-Ann Gonzales, RAC

HIV Genotyping
Providing key information in the treatment of HIV patients
Tuesday, May 28, 2013

Prenatal Group B Strep Tests
Making the early days of life that much safer
Thursday, May 16, 2013

Glucose Monitoring
A paradigm shift in management of diabetes
Tuesday, May 07, 2013

Change is Coming to CE-IVDD
The EU embraces its inner FDA
Tuesday, December 04, 2012

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New draft guidance on submission requirements for device changes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

Evolution of an Assay Could this also be a revolution in FDA thinking?

Good Grief! FDA's Latest LDT Announcements Here we go again...

Looking Back on the IVD Hall of Fame Even if it's not your list, here's no denying their impact on the practice of medicine

Allomap Making a difference in the lives of heart transplant patients