LDT Guidance Documents... Where are They?

Friday, June 15, 2012
Missing Guidance

As reported in a recent FiercePharma ebook OIVD has developed a set of guidance documents proposing how LDTs should be regulated. Whether we expect to like them or not, many of us are deeply curious to see these documents and start formulating comments.

So where are they?

This came up at last week's FDA-Industry IVD Roundtable. Apparently they are stuck somewhere in OMB. Don St. Pierre quipped that he's offered them his blood to them get these documents moving but "...apparently they don't want my blood." Don, in case you don't already know him, is Deputy Director for New Product Evaluation for OIVD.

If the guidance documents are at OMB, it's not clear exactly where at OMB they are. A quick search of OIRA's review docket doesn't list them. If the White House is delaying review of these documents it wouldn't be the first time politics has trumped consistency. Plan B and a recent New York Times article suggest that interference is certainly possible.

Lack of clarity on this issue may be of benefit for some companies but mostly I hear from my clients (LDT, IVD and pharma alike) that being able to anticipate the future, even a more regulated future, is far better than trying to plan for uncertainty. Releasing the draft guidance document would be a big step in letting industry know FDA's thinking on how this could be achieved and allow us to begin concrete planning for the future.

I'd be happy to be a blood donor, too. Maybe if we call get together on this we can make something happen.


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!