Blog Posts with Tag: FDA

The Staple That Changed an Industry
LDT regulation and the perils of challenging Eminem to a rap battle
Tuesday, August 05, 2014
FDA Releases the Kraken
Whichever way this breaks, it's long past time to have this conversation in a meaningful way
Thursday, July 31, 2014
Process Performance Qualification (PPQ) Lots
So, how many lots are required?
Tuesday, June 10, 2014
The Case for Risk-based Monitoring
Better the devil you know...
Thursday, June 05, 2014
A First Look at a New Review Paradigm
Working the bugs out of new methods for identifying bugs
Monday, April 14, 2014
FDA Announces New EUO Label
Draft guidance will lay out new path for devices
Tuesday, April 01, 2014
Risk-Based Quality Management of Clinical Trials
US and EU take (somewhat) similar approaches
Friday, January 31, 2014
No Substitute for Planning
Expecting a miracle isn't the best strategy
Monday, December 23, 2013
RUO + NGS = FDA FTW
MolDx and the prisoner's dilemma
Friday, December 06, 2013
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
Goldilocks and Mobile Healthcare
The FDA guidance on Mobile Medical Apps gets it “just right”
Tuesday, October 01, 2013
Breakthrough Therapies and CoDx
Proposals to help CoDx products keep up with Breakthrough Therapies
Tuesday, September 24, 2013
New Standards for Influenza Tests
FDA moving the bar up for performance
Friday, September 13, 2013
The Sunshine Act Final Rule
Healthy Transparency, But Will It Change Anything?
Wednesday, July 03, 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
TDM Assays
The net under the safe and effective tightrope
Friday, May 17, 2013
Myocardial Infarction Panels
Is it a heart attack, or just heartburn?
Tuesday, May 14, 2013
Blood screening for Hepatitis B & C
Helping keep livers safe for over 20 years
Monday, May 06, 2013
Biomarkers Are Not Magical
Let's be careful not to over-hype a good thing
Thursday, April 25, 2013
Taming the Elephant in the Room
Another small step forward in the regulation of molecular diagnostics
Tuesday, April 16, 2013
Life on the A-List
FDA seems to be sending mixed messages on LDTs and CoDx
Friday, March 22, 2013
Communications Breakdown
FDA’s bold new mission to prove the cynics right
Thursday, March 07, 2013
Not Just Another Biomarker Meeting?
The IOM takes on co-development
Friday, March 01, 2013
Reviewing the Draft Guidance on IRB Responsibilities
It's so succinct it almost fits in a Tweet!
Wednesday, February 20, 2013
The Search for Shortcuts to Market
Companion Diagnostics and the Use of Enrichment Designs
Tuesday, February 05, 2013
The Pre-Submission Rosetta Stone
Translating FDA's Pre-Sub guidance into CoDx language
Friday, February 01, 2013
Paper is (Mostly) Dead
How I learned to stop worrying and love eCopies
Thursday, January 10, 2013
Taxing Compliance
The ambiguity of "device" takes on a whole new importance
Friday, December 07, 2012
Reframing the Discussion
Should market size dictate regulatory enforcement?
Monday, November 19, 2012
Return of the Crystal Ball
What does an Obama re-election portend for the next four years?
Wednesday, November 07, 2012
Companion Diagnostics: LDTs Need Approval Too
The past is the past and tropism won't happen again
Tuesday, June 26, 2012
Reorganization at OIVD
New products, new people, new systems
Wednesday, June 20, 2012
Pre-IDE: How Much is Enough?
How do I know what information to put in a pre-IDE?
Wednesday, May 30, 2012
The Dream of the 90s is Alive at CBER
OraSure's at-home HIV test delivers on 20 years of effort
Wednesday, May 16, 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
Oragene Clearance Shows DNA Stabilization is Class II
Clearance could have a significant impact on DTCG providers
Thursday, December 08, 2011
My Screening Test for Screening Tests
Offering up a rare bit of regulatory certainty
Wednesday, December 07, 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
Pathway's New World of Hurt
Finding the quickest pathway to a warning letter
Wednesday, September 28, 2011
Another Important Guidance Document: Risk & Benefit
No more back-of-the-envelope risk analysis
Tuesday, September 20, 2011
Policy Change We Can Believe In
Our RUO Guidance Comments
Tuesday, August 30, 2011
Promise and Peril in Diagnostics
Outgrowing good guys and bad guys
Tuesday, August 16, 2011
CU Bhind gym 2day 4real, LOL -FDA
Who says the federal government doesn't get new media?
Tuesday, July 19, 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 + NGS = BFFs
We may be talking about a whole new regulatory paradigm when it comes to next-gen sequencing
Friday, June 24, 2011
Moving Beyond Fear
Charting a path through the new RUO landscape
Thursday, June 16, 2011
RU O Kidding? OMG!
Draft RUO / IUO FDA Guidance Document Officially Released
Wednesday, June 01, 2011
The Incredible $24 Million 510(k)
It's foolish to use early meetings as evidence of FDA burden
Tuesday, November 23, 2010
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
Mind Your PQ's (and IQ's and OQ's)
These terms aren't defined in regulation, so what exactly do they mean?
Tuesday, October 05, 2010
Hearing Global Harmonization
Getting a handle on national and regional requirements can be time-consuming
Tuesday, September 28, 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
The Trouble With Transparency
Sunlight may be the best disinfectant, but too much of it can cause melanoma.
Thursday, June 24, 2010
Getting DTC Genomics Right
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
Pathway's Direct-to-Recall Marketing
The perils of making a deal to sell an unapproved IVD direct to consumer.
Tuesday, May 11, 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
The Perils of Time Travel
Some questions you should ask (and FDA will ask) about your frozen clinical samples.
Tuesday, April 13, 2010
Patent (Had Better Be) Pending
The days of using the term as an empty threat may be ending.
Monday, March 08, 2010
Good Summary Judgment
Make it easy to understand your point. It's worth the effort.
Wednesday, March 03, 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
Recent Reflections
Some important details that could help or hinder an application.
Monday, November 16, 2009
New Carrots, New Sticks
Top impressions from Dr. Hamburg's FDLI remarks
Friday, August 07, 2009
A New, Tougher FDA?
The days of "black box" LDTs are likely drawing to a close.
Wednesday, July 29, 2009
510(k)s Facing a "Hard Look"
You don't have to be part of the anti-regulation crowd to be concerned about narrowing the middle ground in this arena.
Thursday, June 18, 2009
A More Aggressive Posture
Consider yourself warned.
Wednesday, June 17, 2009
CE Mark is Good, FDA Clearance is Great
Perhaps it is because of our regulation of the medical marketplace that it is such a valuable space to do business.
Monday, June 08, 2009
A Statement of (Unreviewed) Beliefs
Sure, I got my information from a television commercial, but if you can’t believe television, what can you believe?
Wednesday, May 27, 2009
And the Award Goes To...
Not every regulatory process is a joy, but projects like this can serve to remind us why all of this is worthwhile.
Friday, May 22, 2009
Careful with Claims
It can be frustrating to 'just know' your product can do more, but making claims that are not truly validated is simply unwise.
Monday, May 11, 2009
The Right Balance
What are they actually asking for by urging a "risk-based" regulatory framework for IVDs and LDTs?
Friday, May 08, 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
Can I Get an EUA Too?
The short answer is no, you probably can't get an EUA. Not unless you're the CDC or the stars have all come together for you just right.
Thursday, April 30, 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
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
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
Old Devices are New Again
FDA is reviewing pre-amendent devices.
Wednesday, April 08, 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
Tips 9 & 10
Manufacturing before trials, Focus
Friday, March 13, 2009
Tips 7 & 8
Review contracts, public statements
Thursday, March 12, 2009
Tips 5 & 6
Teamwork, education
Wednesday, March 11, 2009
Tips 3 & 4
Prompt QSR, listening to FDA
Tuesday, March 10, 2009
Tips 1 & 2
Business planning, starting with design control
Monday, March 09, 2009
Genentech Citizen's Petition
There is no public safety reason why the distribution method of diagnostic products should change their regulatory requirements.
Saturday, December 13, 2008
"Serious Misconduct" Alleged at CDRH
The more power an FDA approval holds, the more pressure may be brought to bear on those who make evaluations.
Tuesday, November 18, 2008

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!