FDA Releases Plan For Enhancing eMDR Adverse Event Reporting System
The US agency has announced some changes it plans to make to its electronic Medical Device Reporting system over the coming year.
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Adverse Event Codes From IMDRF Now Used By FDA’s eMDR System
The US FDA has updated its electronic Medical Device Reporting system to accept adverse event codes devised by the International Medical Device Regulators Forum. The agency is urging reporters using an AS2 submission account to “update their systems as soon as possible.”
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.