Blog Posts with Tag: IVD

Form Follows Function
OIR Reorganizes to Meet the Advancing Wave of Molecular Diagnostics
Monday, May 05, 2014
The Hero We All Needed
Lessons from boy that wanted to be Batman
Tuesday, November 19, 2013
Evolution of an Assay
Could this also be a revolution in FDA thinking?
Thursday, June 06, 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
Making a difference in the lives of heart transplant patients
Thursday, May 30, 2013
A crucial marker in the fight against leukemia
Wednesday, May 29, 2013
HIV Genotyping
Providing key information in the treatment of HIV patients
Tuesday, May 28, 2013
BNP tests
Reducing the time to treatment for patients with heart failure
Thursday, May 23, 2013
HPV Tests
Helping to allay women's fears about a life-threatening disease
Wednesday, May 22, 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
TDM Assays
The net under the safe and effective tightrope
Friday, May 17, 2013
Prenatal Group B Strep Tests
Making the early days of life that much safer
Thursday, May 16, 2013
Myocardial Infarction Panels
Is it a heart attack, or just heartburn?
Tuesday, May 14, 2013
Pre- and Postnatal CF Screening
Early detection = better prognosis
Friday, May 10, 2013
HER2/Neu Assay
The prototype for all companion diagnostic tests
Thursday, May 09, 2013
Lipid Profiling
The tests that made HDL and LDL household acronyms
Wednesday, May 08, 2013
Glucose Monitoring
A paradigm shift in management of diabetes
Tuesday, May 07, 2013
Blood screening for Hepatitis B & C
Helping keep livers safe for over 20 years
Monday, May 06, 2013
HIV Viral Load
The test that changed HIV treatment forever
Thursday, May 02, 2013
Come Celebrate IVD Appreciation Month!
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
Taming the Elephant in the Room
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
Change is Coming to CE-IVDD
The EU embraces its inner FDA
Tuesday, December 04, 2012
OIG Signals Interest in LDTs
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
LDT Guidance Documents... Where are They?
For better or worse, shouldn't we at least see them?
Friday, June 15, 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
My Screening Test for Screening Tests
Offering up a rare bit of regulatory certainty
Wednesday, December 07, 2011
The Invisible Hand Pushes Back
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
RUO Enforcement Begins?
FDA throws down the gauntlet
Friday, September 30, 2011
Finding the Right Regulation
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
Guidance Document Mania!
The string of hits from CDRH keeps coming
Friday, September 09, 2011
Promise and Peril in Diagnostics
Outgrowing good guys and bad guys
Tuesday, August 16, 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
IVD Roundtable Meeting Recap
No knights, but plenty of great discussion nonetheless.
Monday, June 13, 2011
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
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
Putting the "Lab" Back in LDTs
Clinical labs: FDA is not interested in shutting you down after the LDT meeting
Thursday, July 29, 2010
FDA's LDT Meeting Slides
Serrano, Harper & Mansfield
Tuesday, July 27, 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
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
The Wrong Raptor
Offering a successful LDT may be about the same amount of work as a full FDA submission.
Monday, July 12, 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
I wouldn't be surprised if this is the first step in a larger re-alignment of regulatory burdens.
Thursday, January 14, 2010
A New, Tougher FDA?
The days of "black box" LDTs are likely drawing to a close.
Wednesday, July 29, 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
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
IVD's and LDT's - What's the difference?
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
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

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!