UPTON/ESHOO DEVICE REFORM BILL DESIGNED TO DRAW ATTENTION TO RISK-BASED CLASSIFICATION OF NOVEL DEVICES, FDA RECOGNITION OF CONSENSUS STANDARDS
This article was originally published in The Gray Sheet
Executive Summary
A stand-alone device reform bill slated to be introduced by Reps. Fred Upton (R-Mich.) and Anna Eshoo (D-Calif.) on April 29 will propose provisions to allow FDA to classify novel technologies according to risk and to clarify FDA's ability to adopt consensus standards.
You may also be interested in...
Cochlear’s Osia System Receives Expanded FDA Clearance For Use In Younger Children
Kids ages 5 and up now can benefit from Cochlear’s Osia implant and sound processor, indicated for hearing loss, mixed hearing loss and single-sided sensorineural deafness.
MAISI: Navigating The 'Valley Of Death' In Medtech Research Translation
Translating research from proof of concept to clinical investigations is a difficult hurdle to overcome. To succeed, researchers need to design their technology for industrial standard manufacturing early on, Anne Vanhoestenberghe, director for the Manufacture of Active Implants and Surgical Instruments (MAISI), told Medtech Insight.
Incyte Hopes To Augment Immune/Inflammation Pipeline With Escient Deal
Incyte will pay $750m to acquire privately held Escient and its first-in-class oral antagonists of Mas-related G protein-coupled receptors X2 and X4.