Blog Posts with Tag: CDRH

The Spirit of GLP
A Best Practice for IVDs
Tuesday, June 17, 2014
Process Performance Qualification (PPQ) Lots
So, how many lots are required?
Tuesday, June 10, 2014
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
Immediately in Effect Guidance
In your role as a regulatory professional, chances are you have faced this situation
Tuesday, April 22, 2014
Final RUO Guidance: First Impressions
FDA appears ready to get serious about RUO
Friday, November 22, 2013
FDA Only Half Closed For Business
Another gift from Congress that keeps on giving
Wednesday, October 09, 2013
Laboratory Developed Tests
Is something brewing in the world of home brews?
Thursday, July 11, 2013
Evolution of an Assay
Could this also be a revolution in FDA thinking?
Thursday, June 06, 2013
Waiting for LDT Guidance
What happens when Samuel Beckett, Tim Burton, and IVDs all meet at AMDM.
Tuesday, April 23, 2013
A CDISC Primer
What is CDISC, and why should I care?
Friday, April 12, 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
Reviewing the Draft Guidance on IRB Responsibilities
It's so succinct it almost fits in a Tweet!
Wednesday, February 20, 2013
The Pre-Submission Rosetta Stone
Translating FDA's Pre-Sub guidance into CoDx language
Friday, February 01, 2013
Acceptance Criteria Top 10 List
From the home office in Redwood Shores, CA
Wednesday, December 12, 2012
Exploring Bias
An ongoing adventure for a non-statistician
Wednesday, November 14, 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
LDT Guidance Documents... Where are They?
For better or worse, shouldn't we at least see them?
Friday, June 15, 2012
New PDS More Cumbersome?
We're cautiously pessimistic on the new de novo guidance
Tuesday, October 04, 2011
Another Important Guidance Document: Risk & Benefit
No more back-of-the-envelope risk analysis
Tuesday, September 20, 2011
Surpriseless in Silver Spring
Some thoughts on the CDRH/IOM Meeting
Friday, September 16, 2011
Guidance Document Mania!
The string of hits from CDRH keeps coming
Friday, September 09, 2011
Policy Change We Can Believe In
Our RUO Guidance Comments
Tuesday, August 30, 2011
To File or Not to File, That is the Question
New draft guidance on submission requirements for device changes
Monday, August 08, 2011
Fixing / Demolishing the 510(k)
The changes IOM proposes are both radical and entirely sensible
Monday, August 01, 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
Moving Beyond Fear
Charting a path through the new RUO landscape
Thursday, June 16, 2011
IVD Roundtable Meeting Recap
No knights, but plenty of great discussion nonetheless.
Monday, June 13, 2011
RU O Kidding? OMG!
Draft RUO / IUO FDA Guidance Document Officially Released
Wednesday, June 01, 2011
The Big 510(k) Non-Announcement
It's more or less status quo for IVDs
Friday, January 21, 2011
The Incredible $24 Million 510(k)
It's foolish to use early meetings as evidence of FDA burden
Tuesday, November 23, 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 Trouble With Transparency
Sunlight may be the best disinfectant, but too much of it can cause melanoma.
Thursday, June 24, 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
Bells, Whistles, and the Quest for Clinical Utility
Increasingly, FDA is becoming reluctant to clear tests that have a vague or general clinical utility.
Thursday, November 05, 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
Old Devices are New Again
FDA is reviewing pre-amendent devices.
Wednesday, April 08, 2009
"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!