Blog Posts with Tag: PMA

CDRH Unveils New PMA Guidance Documents
Attention shoppers, it's two-for-one day!
Tuesday, April 29, 2014
FDA Only Half Closed For Business
Another gift from Congress that keeps on giving
Wednesday, October 09, 2013
Paper is (Mostly) Dead
How I learned to stop worrying and love eCopies
Thursday, January 10, 2013
Waiting for Guidance
When will it be time for a final decision on LDTs?
Monday, June 11, 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
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
The Incredible $24 Million 510(k)
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
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
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
Stability Studies — Is accelerated data enough?
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

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!