Post-Approval Study Data Can Be Obtained From Registries, FDA Says
This article was originally published in The Gray Sheet
Executive Summary
FDA is urging manufacturers to tap into data from existing device registries to help fulfill post-approval study requirements in a practical way
You may also be interested in...
FDA Expects Draft Document On Post-Approval Study Design By September
FDA hopes to complete a draft scientific document on how to design post-approval studies for medical devices by September, according to Danica Marinac-Dabic, director of the Division of Epidemiology within CDRH's Office of Surveillance and Biometrics
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.