My Screening Test for Screening Tests
Offering up a rare bit of regulatory certainty
Wednesday, December 07, 2011
Offering up a rare bit of regulatory certainty
Wednesday, December 07, 2011
Yes, That's a Device
How can software or an algorithm be considered a "device" if it's not a physical thing?
Thursday, October 07, 2010
How can software or an algorithm be considered a "device" if it's not a physical thing?
Thursday, October 07, 2010
No Simple Answers
Becoming a real participant begins with a willingness to engage the details.
Wednesday, June 30, 2010
Becoming a real participant begins with a willingness to engage the details.
Wednesday, June 30, 2010
The Trouble With Transparency
Sunlight may be the best disinfectant, but too much of it can cause melanoma.
Thursday, June 24, 2010
Sunlight may be the best disinfectant, but too much of it can cause melanoma.
Thursday, June 24, 2010
LDT: Legal Distinction Terminated
OIVD will no longer observe a significant distinction between IVDs and LDTs.
Monday, June 21, 2010
OIVD will no longer observe a significant distinction between IVDs and LDTs.
Monday, June 21, 2010
Getting DTC Genomics Right
Personal genomics must move beyond the phase of repackaging preliminary research as actionable information.
Friday, May 21, 2010
Personal genomics must move beyond the phase of repackaging preliminary research as actionable information.
Friday, May 21, 2010
Pathway's Looming World of Hurt
Thank your for your willingness to invite FDA enforcement in public.
Wednesday, May 12, 2010
Thank your for your willingness to invite FDA enforcement in public.
Wednesday, May 12, 2010
Pathway's Direct-to-Recall Marketing
The perils of making a deal to sell an unapproved IVD direct to consumer.
Tuesday, May 11, 2010
The perils of making a deal to sell an unapproved IVD direct to consumer.
Tuesday, May 11, 2010
Good Summary Judgment
Make it easy to understand your point. It's worth the effort.
Wednesday, March 03, 2010
Make it easy to understand your point. It's worth the effort.
Wednesday, March 03, 2010
Four Eighty Threes, Three French Hens...
Hopefully you've never been issued a warning letter, so I'd like to walk you through what a typical one looks like.
Monday, December 21, 2009
Hopefully you've never been issued a warning letter, so I'd like to walk you through what a typical one looks like.
Monday, December 21, 2009
Clove Madness
You're not supposed to admire the work of lobbyists, but this is pretty impressive.
Monday, November 30, 2009
You're not supposed to admire the work of lobbyists, but this is pretty impressive.
Monday, November 30, 2009
Recent Reflections
Some important details that could help or hinder an application.
Monday, November 16, 2009
Some important details that could help or hinder an application.
Monday, November 16, 2009
Headed to the Hoosegow
Those of us who manage to pursue our work in a more conscientious manner shouldn't worry too much.
Tuesday, November 10, 2009
Those of us who manage to pursue our work in a more conscientious manner shouldn't worry too much.
Tuesday, November 10, 2009
Letter to an Aspiring RA Professional
Breaking into RA is all about that first job and what you do with it.
Monday, September 07, 2009
Breaking into RA is all about that first job and what you do with it.
Monday, September 07, 2009
Making Progress by Crushing Dreams
Some dreams really need a good crushing in order for marketplace credibility to survive.
Thursday, May 28, 2009
Some dreams really need a good crushing in order for marketplace credibility to survive.
Thursday, May 28, 2009
Which V is Which?
hey're often called V&V, but what is the difference, what do they have to do with design control and how do they relate to process validation?
Monday, May 18, 2009
hey're often called V&V, but what is the difference, what do they have to do with design control and how do they relate to process validation?
Monday, May 18, 2009
Too Good to be True?
Perfection is a worthy goal, but it's not often we get to see it out in the field.
Monday, May 04, 2009
Perfection is a worthy goal, but it's not often we get to see it out in the field.
Monday, May 04, 2009
A PMA Is Not the Kiss of Death
The amount of work you need to do for a PMA is not very much larger than the amount you are supposed to do for a 510(k).
Monday, April 27, 2009
The amount of work you need to do for a PMA is not very much larger than the amount you are supposed to do for a 510(k).
Monday, April 27, 2009
Know Your Audience
I have to hope that they might have thought twice about some of these choices if they had realized that FDA was attending the conference.
Wednesday, April 22, 2009
I have to hope that they might have thought twice about some of these choices if they had realized that FDA was attending the conference.
Wednesday, April 22, 2009