CDRH Recalls Report: Growing Recall Count Doesn’t Mean Device Quality Is In Decline
This article was originally published in The Gray Sheet
Executive Summary
A new report released by FDA’s device center concludes that the explosion in device recalls during the past decade is a result of overly sensitive firms cited in the past by FDA for violating its recalls regulation and by makers of radiological products.
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.