FDA Recommends New Warnings on Labels for Laparoscopic Power Morcellator Devices
The Food and Drug Administration issued new guidance on Nov. 24 for labeling of certain medical devices (here). The agency is now recommending manufacturers “prominently include” contraindications and boxed warnings on labeling of laparoscopic power morcellators (here), in light of…
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
the risk that the devices could spread cancer in some situations.