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New draft guidance on submission requirements for device changes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

The Staple That Changed an Industry LDT regulation and the perils of challenging Eminem to a rap battle
FDA Releases the Kraken Whichever way this breaks, it's long past time to have this conversation in a meaningful way
Illumina Acquires Myraqa Acquisition Strengthens Illumina’s Clinical Readiness
The Spirit of GLP A Best Practice for IVDs
Process Performance Qualification (PPQ) Lots So, how many lots are required?
The Case for Risk-based Monitoring Better the devil you know...
Form Follows Function OIR Reorganizes to Meet the Advancing Wave of Molecular Diagnostics
CDRH Unveils New PMA Guidance Documents Attention shoppers, it's two-for-one day!