Mercy, J&J Partner To Evaluate Medical Devices
Executive Summary
As US FDA has been on a quest to encourage gathering more real-world data, companies like Medtronic and Johnson & Johnson seem to be hopping on the bandwagon with partnerships to gather and analyze how their products really perform.
You may also be interested in...
NEST Coordinating Center At Year One: Device Data-Sharing Network In Its Sights
A year after the NEST Coordinating Center was launched, the group has expanded its staff and now it wants to get a data network in place by year's end with real-world evidence information that device manufacturers can use to impress US FDA reviewers.
'Super Office' To The Rescue: FDA's Device Center Is About To Undergo A 'Total Product Life Cycle' Makeover
CDRH Director Jeff Shuren told industry that the device center is moving quickly to establish a "super office" to tackle the full spectrum of pre- and post-market issues to reduce inefficiencies to replace the more siloed approach. Chief Scientist Bill Maisel has already been named a director.
Pilot Of New US Evaluation System Will Include At Least Two Devices
New details about the planned pilot launch of the National Evaluation System for health Technology were included in US FDA's recently posted user-fee reauthorization commitment letter. At least one PMA and one 510(k) product type must be piloted on the real-world evidence system. Device center director Jeff Shuren continued to tout the program at this year's AdvaMed conference.