Policy Change We Can Believe In

Tuesday, August 30, 2011

Myraqa has submitted its final comments to FDA's draft RUO guidance, published June 1.

We welcome the agency's desire to continue elevating the high standards of the IVD industry, but believe that FDA interpretation and policy play a role in the current situation. We have therefore recommended two actions we believe the Agency can and should take if it is to increase enforcement around RUO sales into clinical diagnostics labs:

  1. Allow a broader range of products to qualify as "components" under 21 CFR 820.3(c)

  2. Reconsider or narrow the "system review" policy

Our reasoning and additional detail is provided in our full comments.

I have to admit I have a bit of trepidation about making these recommendations, as I'm typically more comfortable explaining FDA's positions to industry. I do think industry is frequently too quick to criticize FDA, but it may still be the case that there is opportunity for improvement in our regulatory and policy approach.

Thanks to everyone who commented on earlier drafts of these comments. I look forward to seeing what comes next and sharing any additional comments.


Tags: 510(k), Advertising and Promotion, CDRH, Enforcement, FDA, Industry, LDTs, RUO

Other Blog Authors

Dylan Reinhardt
Dave Kern
Steve Gutman
Jo-Ann Gonzales

Recent Blog Posts

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!