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
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
OraSure's at-home HIV test delivers on 20 years of effort
Wednesday, May 16, 2012
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
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
Life on the A List
Requirements for List A products are similar to those for a PMA
Tuesday, November 09, 2010
Requirements for List A products are similar to those for a PMA
Tuesday, November 09, 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 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
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
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
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