Pre-IDE: How Much is Enough?
How do I know what information to put in a pre-IDE?
Wednesday, May 30, 2012
How do I know what information to put in a pre-IDE?
Wednesday, May 30, 2012
Oragene Clearance Shows DNA Stabilization is Class II
Clearance could have a significant impact on DTCG providers
Thursday, December 08, 2011
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
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
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
Pathway's New World of Hurt
Finding the quickest pathway to a warning letter
Wednesday, September 28, 2011
Finding the quickest pathway to a warning letter
Wednesday, September 28, 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New draft guidance on submission requirements for device changes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New draft guidance on submission requirements for device changes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
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
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
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
Good Summary Judgment
Make it easy to understand your point. It's worth the effort.
Wednesday, March 03, 2010
Make it easy to understand your point. It's worth the effort.
Wednesday, March 03, 2010
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
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
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
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
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
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
IVDMIA: Any Day Now?
One thing I can say for sure: IVDMIA's passage would significantly change risk calculations for LDTs that qualify as mutivariate.
Monday, November 17, 2008
One thing I can say for sure: IVDMIA's passage would significantly change risk calculations for LDTs that qualify as mutivariate.
Monday, November 17, 2008
Stability Studies — Is accelerated data enough?
The time between testing points is a choice to be made for each product.
Wednesday, October 01, 2008
The time between testing points is a choice to be made for each product.
Wednesday, October 01, 2008
Specimen Preparation Systems: Insider Info
What happens when you joke about starting a blog.
Friday, August 15, 2008
What happens when you joke about starting a blog.
Friday, August 15, 2008