FDA Surprised By Device Manufacturer's Quick Consent Decree Turnaround
This article was originally published in The Silver Sheet
Executive Summary
WHEN A DEVICE MANUFACTURER ENTERS INTO A CONSENT DECREE with FDA, it often takes years to solve its quality systems problems and obtain clearance to begin selling its devices again. However, Custom Ultrasonics, a Pennsylvania maker of endoscope disinfection systems, worked through its consent decree in less than four months. “It's the fastest I've seen around here,” CDRH Compliance Director Tim Ulatowski says. Ulatowski says FDA will consider making more use of consent decrees rather than issuing multiple warning letters to companies. Legal experts discuss how firms should handle a consent decre
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.