‘Big Data’ Poses New Product Recall Challenges, FDA Official Says
Executive Summary
Officials with the US FDA discussed new challenges the information economy poses to the agency’s recalls process at a recent conference, as well as techniques manufacturers can use to better work with the agency’s recall staff.
You may also be interested in...
Total Recall: FDA Final Guidance Says Firms Should Publicize Recalls Until Problem Products No Longer Used
Recall announcements should be readily accessible to the public until recalled products are gone from the market, US FDA recommends in a new corrections and removals guidance that covers all goods regulated by the agency.
Report Finds Digital Diabetes Tools Deliver No ‘Meaningful Clinical Benefits'
A new report from health economics group the Peterson Health Technology Institute found that apps to help patients manage their blood sugar levels delivered few of the promised benefits. However, a digital therapeutics industry association says PHTI’s research cast too narrow a net.
FDA Leader Looks To International Effort On Pediatric Device Development
Collaboration with Japan and Europe could help ease the development path for pediatric devices, cardiovascular device office director Bram Zuckerman said at a recent conference. Zuckerman also spoke on other cardiac device priorities at the FDA.