Rapid Influenza Detection Tests
Helping doctors decide who needs antivirals, and who needs chicken soup
Monday, May 20, 2013
Helping doctors decide who needs antivirals, and who needs chicken soup
Monday, May 20, 2013
Come Celebrate IVD Appreciation Month!
IVD Hall of Fame inductions begin tomorrow
Wednesday, May 01, 2013
IVD Hall of Fame inductions begin tomorrow
Wednesday, May 01, 2013
Waiting for LDT Guidance
What happens when Samuel Beckett, Tim Burton, and IVDs all meet at AMDM.
Tuesday, April 23, 2013
What happens when Samuel Beckett, Tim Burton, and IVDs all meet at AMDM.
Tuesday, April 23, 2013
Taming the Elephant in the Room
Another small step forward in the regulation of molecular diagnostics
Tuesday, April 16, 2013
Another small step forward in the regulation of molecular diagnostics
Tuesday, April 16, 2013
Taxing Compliance
The ambiguity of "device" takes on a whole new importance
Friday, December 07, 2012
The ambiguity of "device" takes on a whole new importance
Friday, December 07, 2012
OIG Signals Interest in LDTs
We are not taking any bets this time around
Wednesday, November 28, 2012
We are not taking any bets this time around
Wednesday, November 28, 2012
Once More Into the Breach Lads!
Is the time finally right for the CLIA lab to IVD business model?
Thursday, September 20, 2012
Is the time finally right for the CLIA lab to IVD business model?
Thursday, September 20, 2012
LDT Guidance Documents... Where are They?
For better or worse, shouldn't we at least see them?
Friday, June 15, 2012
For better or worse, shouldn't we at least see them?
Friday, June 15, 2012
In-Vehicle Diagnostics
Assessing the bold future of automotive medicine
Wednesday, February 29, 2012
Assessing the bold future of automotive medicine
Wednesday, February 29, 2012
Great New Companion Diagnostics E-Book Released Today
A valuable resource in a hot, but under-informed segment of the market
Monday, December 12, 2011
A valuable resource in a hot, but under-informed segment of the market
Monday, December 12, 2011
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
The Abolish OIVD Act of 2011
A torches-and-pitchforks approach to LDT regulations
Tuesday, October 18, 2011
A torches-and-pitchforks approach to LDT regulations
Tuesday, October 18, 2011
The Invisible Hand Pushes Back
A major payer proposes to restrict coverage of LDTs
Monday, October 17, 2011
A major payer proposes to restrict coverage of LDTs
Monday, October 17, 2011
New PDS More Cumbersome?
We're cautiously pessimistic on the new de novo guidance
Tuesday, October 04, 2011
We're cautiously pessimistic on the new de novo guidance
Tuesday, October 04, 2011
Finding the Right Regulation
Some regs are not as obvious as they appear
Thursday, September 29, 2011
Some regs are not as obvious as they appear
Thursday, September 29, 2011
Another Important Guidance Document: Risk & Benefit
No more back-of-the-envelope risk analysis
Tuesday, September 20, 2011
No more back-of-the-envelope risk analysis
Tuesday, September 20, 2011
And in Other News, Nothing Really Changed
FDA draft guidance on In Vitro Companion Diagnostics documents what we've been hearing
Thursday, July 14, 2011
FDA draft guidance on In Vitro Companion Diagnostics documents what we've been hearing
Thursday, July 14, 2011
IVD Roundtable Meeting Recap
No knights, but plenty of great discussion nonetheless.
Monday, June 13, 2011
No knights, but plenty of great discussion nonetheless.
Monday, June 13, 2011
We'll Drink to That
Enforcement discretion is ending. So let’s start with accepting the new reality, then get to work shaping it.
Friday, December 03, 2010
Enforcement discretion is ending. So let’s start with accepting the new reality, then get to work shaping it.
Friday, December 03, 2010
LDTs: Where's the Fire?
The news is not new about LDTs and their impending regulatory oversight.
Wednesday, December 01, 2010
The news is not new about LDTs and their impending regulatory oversight.
Wednesday, December 01, 2010
Life on the A List
Requirements for List A products are similar to those for a PMA
Tuesday, November 09, 2010
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
The route is determined by intended use and risks to personal and public health
Tuesday, November 02, 2010
Lessons Learned in Project Management
Turns out even writing about project management can be a good lesson in the subject matter.
Tuesday, October 19, 2010
Turns out even writing about project management can be a good lesson in the subject matter.
Tuesday, October 19, 2010
Creating Good Connections
Everyone wants a standard whereby tubes can't be mixed up. Why don't we have it?
Thursday, September 30, 2010
Everyone wants a standard whereby tubes can't be mixed up. Why don't we have it?
Thursday, September 30, 2010
A Better 510k Webinar
What happens when your meeting has the agenda of a radio call-in show
Wednesday, September 01, 2010
What happens when your meeting has the agenda of a radio call-in show
Wednesday, September 01, 2010
Putting the "Lab" Back in LDTs
Clinical labs: FDA is not interested in shutting you down after the LDT meeting
Thursday, July 29, 2010
Clinical labs: FDA is not interested in shutting you down after the LDT meeting
Thursday, July 29, 2010
It's My Genome and I'll Do What I Wanna
Mr. Biggers deserves a clear, direct answer to his LDT meeting questions
Thursday, July 22, 2010
Mr. Biggers deserves a clear, direct answer to his LDT meeting questions
Thursday, July 22, 2010
A Hearing... but not a Listening
These aren't new rules. You don't get to keep doing what you're doing.
Monday, July 19, 2010
These aren't new rules. You don't get to keep doing what you're doing.
Monday, July 19, 2010
Keep Calm and Carry On
Whoever says these words to me after Monday's LDT mtg. gets their first drink on me.
Friday, July 16, 2010
Whoever says these words to me after Monday's LDT mtg. gets their first drink on me.
Friday, July 16, 2010
The Wrong Raptor
Offering a successful LDT may be about the same amount of work as a full FDA submission.
Monday, July 12, 2010
Offering a successful LDT may be about the same amount of work as a full FDA submission.
Monday, July 12, 2010
LDTs Losing Enforcement Discretion?
FDA no longer feels the need to bargain with industry about LDTs.
Wednesday, June 16, 2010
FDA no longer feels the need to bargain with industry about LDTs.
Wednesday, June 16, 2010
Unicorns, Santa Claus and Instrument-Only Clearances
Let's be clear, though: the world has not turned topsy-turvy today.
Tuesday, May 04, 2010
Let's be clear, though: the world has not turned topsy-turvy today.
Tuesday, May 04, 2010
ODE to OIVD
I wouldn't be surprised if this is the first step in a larger re-alignment of regulatory burdens.
Thursday, January 14, 2010
I wouldn't be surprised if this is the first step in a larger re-alignment of regulatory burdens.
Thursday, January 14, 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
IVDMIA: No Longer MIA?
I'm sure I'll have more to say when we see the final guidance.
Friday, December 04, 2009
I'm sure I'll have more to say when we see the final guidance.
Friday, December 04, 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
The Incredible Shrinking LDT
I think it's safe to say that there is a shift in thinking at OIVD since Steve Gutman's departure.
Tuesday, September 22, 2009
I think it's safe to say that there is a shift in thinking at OIVD since Steve Gutman's departure.
Tuesday, September 22, 2009
The Last Gasp?
It's a legal Hail Mary pass... the kind of play you attempt when you've already lost anyway.
Monday, August 03, 2009
It's a legal Hail Mary pass... the kind of play you attempt when you've already lost anyway.
Monday, August 03, 2009
A New, Tougher FDA?
The days of "black box" LDTs are likely drawing to a close.
Wednesday, July 29, 2009
The days of "black box" LDTs are likely drawing to a close.
Wednesday, July 29, 2009
What is a "Regulatory Affair" and should I have one?
Perhaps we have more in common with a fiery mistress or hunky boy toy than we might suspect.
Monday, July 13, 2009
Perhaps we have more in common with a fiery mistress or hunky boy toy than we might suspect.
Monday, July 13, 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
Hologic HPV Approvals
This approval clearly demonstrates the FDA’s willingness to work with diagnostic companies on state-of-the-art molecular diagnostic testing.
Friday, April 10, 2009
This approval clearly demonstrates the FDA’s willingness to work with diagnostic companies on state-of-the-art molecular diagnostic testing.
Friday, April 10, 2009
IVD's and LDT's - What's the difference?
Molecular diagnostic tests have two compliant paths to the US market.
Wednesday, April 08, 2009
Molecular diagnostic tests have two compliant paths to the US market.
Wednesday, April 08, 2009
Implications of the New RoHS Directives
It's never too early to learn about the purpose of the RoHS Directive.
Monday, January 26, 2009
It's never too early to learn about the purpose of the RoHS Directive.
Monday, January 26, 2009
Wrong results... again
How can we trust the fancy new molecular test for a particular drug if we can't even get the basics right?
Thursday, January 15, 2009
How can we trust the fancy new molecular test for a particular drug if we can't even get the basics right?
Thursday, January 15, 2009
IEC 60601 vs. IEC 61010
The criteria for selecting the correct standard depends upon whether the device is in the same room as the patient.
Tuesday, January 13, 2009
The criteria for selecting the correct standard depends upon whether the device is in the same room as the patient.
Tuesday, January 13, 2009