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
Reviewing the Draft Guidance on IRB Responsibilities
It's so succinct it almost fits in a Tweet!
Wednesday, February 20, 2013
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
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
From the home office in Redwood Shores, CA
Wednesday, December 12, 2012
Companion Diagnostics: LDTs Need Approval Too
The past is the past and tropism won't happen again
Tuesday, June 26, 2012
The past is the past and tropism won't happen again
Tuesday, June 26, 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
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
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
To File or Not to File, That is the Question
New draft guidance on submission requirements for device changes
Monday, August 08, 2011
New draft guidance on submission requirements for device changes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
The changes IOM proposes are both radical and entirely sensible
Monday, August 01, 2011
Makower Report Discredited. Again.
Grandstanding is a poor way to participate in science policy
Friday, July 29, 2011
Grandstanding is a poor way to participate in science policy
Friday, July 29, 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FDA draft guidance on In Vitro Companion Diagnostics documents what we've been hearing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FDA draft guidance on In Vitro Companion Diagnostics documents what we've been hearing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
RU O Kidding? OMG!
Draft RUO / IUO FDA Guidance Document Officially Released
Wednesday, June 01, 2011
Draft RUO / IUO FDA Guidance Document Officially Released
Wednesday, June 01, 2011
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
The Incredible $24 Million 510(k)
It's foolish to use early meetings as evidence of FDA burden
Tuesday, November 23, 2010
It's foolish to use early meetings as evidence of FDA burden
Tuesday, November 23, 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
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
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
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
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
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
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 Wild West Gets Running Water
There are, in effect, two classes of regulation. Some products undergo rigorous testing and others simply don't.
Friday, November 21, 2008
There are, in effect, two classes of regulation. Some products undergo rigorous testing and others simply don't.
Friday, November 21, 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
The more power an FDA approval holds, the more pressure may be brought to bear on those who make evaluations.
Tuesday, November 18, 2008