FDA Grants Class II Status For Power Morcellator Containment Systems
This article was originally published in The Gray Sheet
The agency will require 510(k) clearance for the devices, which can be used to isolate tissue removed from the uterus during morcellation. However, labeling will need to state that the systems have not been proven to reduce the risk of cancer.
You may also be interested in...
The US Patent Office has rejected a request by Edwards LifeSciences to review an Abbott patent on heart-valve technology, which could establish the patent as a key part of Abbott Laboratories’ arguments in a larger ongoing intellectual property case.
Through a draft guidance, the US agency has established performance criteria for magnetic resonance coils, making the devices eligible for the standards-based Safety and Performance Based Pathway.
Increasing savvy around cybersecurity issues is driving regulators and trade groups to update their approach to the area, speakers from the US FDA and the American Medical Association said at this week’s FDA/CMS Summit.