Blog Posts by Dylan Reinhardt

RUO + NGS = FDA FTW
MolDx and the prisoner's dilemma
Friday, December 06, 2013
Final RUO Guidance: First Impressions
FDA appears ready to get serious about RUO
Friday, November 22, 2013
Our Point of Care Future
It's not just for chemistry tests any more
Monday, September 16, 2013
Communications Breakdown
FDA’s bold new mission to prove the cynics right
Thursday, March 07, 2013
Paper is (Mostly) Dead
How I learned to stop worrying and love eCopies
Thursday, January 10, 2013
Taxing Compliance
The ambiguity of "device" takes on a whole new importance
Friday, December 07, 2012
Return of the Crystal Ball
What does an Obama re-election portend for the next four years?
Wednesday, November 07, 2012
Welcoming Our New OIRA Overlords
Will necessity and harmonization trigger a regulatory race to the bottom?
Monday, June 18, 2012
Finding the Right Regulation
Some regs are not as obvious as they appear
Thursday, September 29, 2011
Surpriseless in Silver Spring
Some thoughts on the CDRH/IOM Meeting
Friday, September 16, 2011
Promise and Peril in Diagnostics
Outgrowing good guys and bad guys
Tuesday, August 16, 2011
CU Bhind gym 2day 4real, LOL -FDA
Who says the federal government doesn't get new media?
Tuesday, July 19, 2011
Yes, That's a Device
How can software or an algorithm be considered a "device" if it's not a physical thing?
Thursday, October 07, 2010
The Trouble With Transparency
Sunlight may be the best disinfectant, but too much of it can cause melanoma.
Thursday, June 24, 2010

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!