FDA Warning Letter Recap, December 2021: Medtronic Feels The Heat
Quality systems and Medical Device Reporting violations were noted by US FDA investigators during an on-site inspection of Medtronic’s Northridge, CA, facility. A total of seven device-related warning letters were released by the agency last month.
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Insulin Pump Recall Leads To FDA Warning Letter For Medtronic
The missive reflects quality systems issues at the Northridge, CA headquarters of Medtronic’s diabetes division. Analysts are split on what the warning letter’s long-term impact may be.
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.