UDI System May Result In Smaller Recalls, Improve Adverse Event Reporting
This article was originally published in The Silver Sheet
Executive Summary
FDA's Proposed Rule For Unique Device Identification System Coming This Year
You may also be interested in...
Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?
Thumbs Up: FDA Authorizes Weight Loss Suturing Systems From Apollo Endosurgery
People with obesity now have new tools to help them lose weight, thanks to the US agency’s de novo authorization.
FDA Slaps High Risk Class I Label On Recall Of COVID-19 Diagnostics Made In Uncontrolled Plant
More than 160,000 of the tests were recalled, including 104,900 COVID Test Kits Nonsterile and 61,500 Clean Catch Urine Kits.