Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA releases de novo guidance
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FDA Warns Clinics For Unlawful Advertising Of Allergan’s Lap-Band
Billboards and advertising inserts promoted the Lap-Band procedure without providing adequate risk information, FDA charges.
Safety Concerns Sink Medtronic A-Fib Catheter Ablation System At Panel
Risks associated with Medtronic’s Phased RF catheter ablation system for atrial fibrillation outweigh the benefits of the device, FDA’s Circulatory System Devices panel concluded in an 8-2 vote on Oct. 27.
Need More Women For Device Trials? Create Better Consent Forms, FDA Says
Enrolling women and minorities in device trials remains a challenge. One potential solution highlighted at a recent FDA meeting: improve communication of potential treatment risks.