Reorganization at OIVD

Wednesday, June 20, 2012

At the AMDM Roundtable meeting on June 7th Don St. Pierre from OIVD announced a reorganization of OIVD that is beginning to take shape and will start to be implemented at the end of 2012. It seems OIVD has been doing such a great job that FDA management has decided they need more work to do (that'll teach 'em). OIVD will be taking on additional responsibilities for radiological diagnostic products as well as mammography quality standards. Don also mentioned that OIVD will be taking on oversight of the artifical pancreas project as well.

Since the office won't be just IVDs any more they are working on a catchy new office name. The current working title is Office of In Vitro Diagnostics and Radiological Products (to be abbreviated OIR). In addition, they are also working on adding in additional layers of management with in each of the divisions. Each of the current divisions will end up with branches similar to the organization of ODE. This will bring the current manager to employee ratio to a more reasonable level and facilitiate training of new personnel who are being brought aboard now to ensure there is adequate personnel to complete reviews and other projects.

With all of these changes and lots of new products and people FDA is anticipating the need for more enhanced training programs for both managers and reviewers. Don put out a figure that about 60% of the reviewers within OIVD have less than 3 years of review experience. Given this situation, leadership is working on three training programs for new members of mangement, reviewers as well as a leadership enhancement program for those members of the team already in management.

Don stated he expects the new office to include about 250 people which will be a lot to handle. Along with all of the personnel changes going on, FDA is also working on significant upgrades to their IT systems and database in order to facilitate logging and tracking of information.

There were lots of questions from the crowd on how all these changes will effect reviews and ongoing projects. Don assured the audience that management will do it's best not to disrupt current reviews and to also give us as much information as possible as the plans develop. Don even asked the audience to give FDA thoughts on which information is helpful to know and the best way to communicate. I'll be following up on that request in future blogs.

Thank you Don for giving industry a head's up on all that is happening. We'll looking forward to working with you as the office gets bigger and better.

 

 

Tags: CDRH, FDA

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!