Blog Posts by Steve Gutman, MD

Form Follows Function
OIR Reorganizes to Meet the Advancing Wave of Molecular Diagnostics
Monday, May 05, 2014
CDRH Unveils New PMA Guidance Documents
Attention shoppers, it's two-for-one day!
Tuesday, April 29, 2014
A First Look at a New Review Paradigm
Working the bugs out of new methods for identifying bugs
Monday, April 14, 2014
FDA Regulation of Molecular Diagnostics- Getting it Right
Striving for quality should be the goal
Tuesday, January 14, 2014
The CMS Take on LDTs, CLIA and FDA
Not a rose by any other name
Friday, October 25, 2013
FDA Only Half Closed For Business
Another gift from Congress that keeps on giving
Wednesday, October 09, 2013
How Much Are Lab Tests Really Worth?
Charting a re-direction from a vicious to a virtuous cycle in test development
Wednesday, September 18, 2013
Everything That Rises Must Converge
the CMTP issues new guidance on how to identify cancer tests that work
Tuesday, August 06, 2013
Laboratory Developed Tests
Is something brewing in the world of home brews?
Thursday, July 11, 2013
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
Friday, May 31, 2013
Molecular Diagnostics for Influenza
Making point-of-care diagnosis possible
Tuesday, May 21, 2013
Rapid Influenza Detection Tests
Helping doctors decide who needs antivirals, and who needs chicken soup
Monday, May 20, 2013
Taming the Elephant in the Room
Another small step forward in the regulation of molecular diagnostics
Tuesday, April 16, 2013
Choosing Wisely
Can Informed Patients Help Improve Health Care Quality and Reduce Costs?
Tuesday, March 26, 2013
Not Just Another Biomarker Meeting?
The IOM takes on co-development
Friday, March 01, 2013
The Search for Shortcuts to Market
Companion Diagnostics and the Use of Enrichment Designs
Tuesday, February 05, 2013

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!