Artificial embolization devices
This article was originally published in The Gray Sheet
Executive SummaryPreamendment Class III artificial embolization devices for neurological use are unanimously (7-0) recommended for downclassification to Class II at a June 12 Neurological Devices Panel meeting. The devices obstruct blood flow to an aneurysm or other vascular malformation. The recommendation is based on data submitted to the agency by three manufacturers following an FDA call for data under Sec. 515(i) of device law and presented to the panel by FDA. Panel members note that the products have been used safely and effectively for more than 20 years. Suggesting that additional labeling should be required that emphasizes that only specially trained surgeons use the product, the panel agrees that special controls would be sufficient to ensure safety
You may also be interested in...
US investigators fan out to non-China inspection priorities and Secretary Azar talks supply management; warning letters hit record keeping, investigations and basic GMP compliance.
Mallinckrodt to pay $1.6bn and place its generics unit in bankruptcy under agreement in principle for US global settlement; six states are not on board, including New York, whose suit is still set to go to trial March 20.
The company has reached a broad opioid settlement agreement in principle under which its specialty generics subsidiaries would file for Chapter 11 bankruptcy and Mallinckrodt's branded business would operate separately.