ARTICLE SUMMARY:
The device center has created some new positions over the past few months. Here’s the lowdown on notable additions to CDRH’s organizational structure we have noticed, and vacancies to watch.
[Editor’s note: This article has been updated to clarify the Associate Director for TPLC position is linked to the new TPLC Advisory Program (TAP) pilot.]
FDA’s device center is expected to ramp up hiring now that the new MDUFA V user fee program, including increased industry fees for all submission types, is in place as of October 1. In advance of the changeover, Market Pathways has noticed a few updates within CDRH’s organizational structure that are worth watching:
TAP Point Person
Last month, CDRH added a new title to the Office of Product Evaluation and Quality (OPEQ)’s management structure—Associate Director for TPLC, a post that will serve a liaison to the nascent TPLC Advisory Program (TAP) pilot within the office that houses all device premarket review staff. Veteran cardiovascular device reviewer Matthew Hillebrenner was recently tapped to fill the role on an acting basis.
