Device Review Program Faces Organizational Changes; User Fees Coming?
This article was originally published in The Silver Sheet
Executive Summary
NOVEL DEVICE PREMARKET REVIEW OPTIONS will be a primary focus of the Center for Devices and Radiological Health’s new office dedicated to in vitro diagnostic products. The IVD office will embody the device center’s "total product life cycle" approach to regulating products, which seeks to eliminate the division between premarket and postmarket activities. A new division devoted to cardiovascular devices, new leadership and the possibility of user fees are among the changes facing the CDRH’s Office of Device Evaluation. Meanwhile, ODE looks for ways to improve its expedited and modular PMA options and to encourage greater use of abbreviated 510(k)s and third parties
You may also be interested in...
Metsera Launches As New Obesity Contender Flush With $290m
Clive Meanwell, former CEO of The Medicines Company, will helm the new company, backed by ARCH and other investors. He talked to Scrip about the new venture.
Deal Watch: AbbVie Teams With MedinCell On Long-Acting Injectables
Collaboration Edition: Including deals involving Evotec/Variant, Sanofi/IGM/Nurix, ABVC/OncoX and Harmony/Bioprojet, along with tech transfer agreements and deals in brief.
GE HealthCare Launches AI-Powered Voluson Ultrasound For Women’s Health
Voluson Signature 20 and 18 ultrasound provides clinicians with workflow efficiencies in detecting female reproductive health problems, especially those related to pregnancy.